ENTRHAL MEDICAL GmbH

Name

ENTRHAL MEDICAL GmbH

Legal name

Entrhal Medical GmbH

Website

https://entrhal-medical.de

Company type

Private

Founded year

1985

Operating status

Operating

Headcount range

11–50 employees

Short description

ENTRHAL MEDICAL GmbH is a German MedTech company that manufactures and distributes sealing devices, quality assurance test equipment, and single-use surgical instruments for hospital CSSD/AEMP sterile supply departments across 35+ countries.

Ownership category

akta.pro rank

Product category

Medical Device Sterilization and Reprocessing Equipment

NAICS

Surgical Appliance and Supplies Manufacturing (339113), Surgical and Medical Instrument Manufacturing (339112)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Single-Use Surgical Devices & Procedure Packs (Disposable instruments, drapes, kits) (HLAHADAM)

Keywords

• Medical device reprocessing
• Sterile packaging equipment
• AEMP CSSD solutions
• Heat sealing devices
• Single-use surgical instruments

Headquarters

HQ city

Straelen

HQ country

Germany

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Supply Chain, Personnel, Technology or R&D, Operations, Marketing or Sales

Revenue model

1. Sealing Equipment and Accessories: Production and distribution of sealing devices (EM 20 KCS, EM 24 KCS, EM 40 KCS) for sterile packaging according to DIN EN ISO 11607-2. Includes accessories like roll holders.
2. Test Equipment: Quality assurance devices including CONTEG container testing systems, Diateg isolation testers, MedZense light cable testers, and test systems (Helix, Bowie & Dick, Wash Test, Seal Test, Ink Test Easy).
3. Single-Use Surgical Instruments: Disposable surgical instruments including standard instruments, ophthalmology, ENT (HNO), and gynecology instruments. Packed in Germany in own cleanroom facility.
4. Service, Maintenance and Calibration: Professional maintenance of devices including replacement of wear parts, visual inspection, functional testing, calibration of process-relevant parameters (temperature, contact pressure, feed speed for sealing devices), and validation services.
5. Instrument Cleaning Equipment: Steam cleaners (AutoSteam, MultiSteam, MaxiSteam), steam boxes, and brushes for internal and external instrument cleaning.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels6 records

Core offering

ENTRHAL MEDICAL GmbH manufactures and sells medical devices for sterile supply and medical device reprocessing, including heat sealing equipment (EM 20/24/40 KCS), test devices for insulation, light transmission and container integrity, single-use surgical instruments packed in its own German cleanroom, and supporting accessories and consumables. The company also provides maintenance, calibration, and validation services for its installed base of equipment in hospitals, AEMP/CSSD departments, and clinics worldwide.

Product overview

ENTRHAL MEDICAL GmbH offers a comprehensive portfolio of medical device products and services focused on sterile supply and medical device reprocessing. The product range is organized into three main product groups: (1) Sealing devices (EM 20/24/40 KCS) with innovative SerVa-Box technology for on-site maintenance; (2) Test devices including DIATEG Professional for insulation testing, MedZense LG20-e/f for light cable testing with IQM software platform, and CONTEG Professional for container testing; (3) Sterile single-use instruments for surgery (Standard, Ophthalmology, ENT, Gynecology). Supporting products include steam cleaners (AutoSteam, MultiSteam, MaxiSteam, SteamBox), VacioPak vacuum packaging system, test consumables (Helix Test, Bowie & Dick Test, Ink Test Easy, Seal Test, Class 5 Indicators), and accessories (sieves/baskets, fixation systems, brushes). Services include maintenance & calibration with annual validation. Products are manufactured with own cleanroom production since September 2023, with capacity of up to 90,000 instruments per week. The company holds ISO 13485 certification and operates with a network of international distributors.

Differentiator

Problem solved

Functional benefit

Brands

• Zign Medical: A product line and partnership brand under Zign Medical B.V., a company partially acquired by Entrhal Medical B.V. in 2018.

Products and services

• EM 20 KCS Heat Sealing Device Compact sealing device with proprietary SerVa-Box technology that enables annual maintenance to be completed on-site by customer staff in under 10 minutes. Conforms to DIN EN ISO 11607-2:2020 for sterile packaging of medical devices. Designed for hospital AEMP/CSSD departments and clinics.
• EM 24 KCS Heat Sealing Device Compact heat sealing device with large clear display for easy handling, tested according to European safety guidelines and meeting DIN EN ISO 11607-2 requirements. Includes factory certificate, operating instructions, and service information. Designed for sterile packaging in hospitals and clinics.
• EM 40 KCS Heat Sealing Device Larger capacity heat sealing device meeting DIN EN ISO 11607-2 requirements, tested according to European safety guidelines. Includes factory certificate, operating instructions, and service information. Used for sterile packaging in hospital AEMP/CSSD departments.
• DIATEG Professional Isolation Tester High-sensitivity voltage testing device for electrosurgical instruments that detects insulation defects such as hairline cracks, micropores, or pinholes non-destructively. Prevents burns and injuries during surgery. Over 500 units deployed in German clinics. Market introduction in 2014.
• MedZense LG20-e/f Light Cable Tester Universal light cable and rigid endoscope tester measuring light transmission across the entire visible light spectrum (diameter 2.7-10mm). Supports all important connections and cable types, includes ENDOYE test option for video laparoscopes, and integrates with IQM system. Used for objective light quality testing in minimally invasive surgery.
• MedZense DMS Data Matrix Scanner DataMatrix scanner for identifying and tracking surgical instruments. Fully compatible with MedZense IQM platform, supports up to 2 test devices in parallel, reads small scratched DataMatrix codes on curved or reflective surfaces, plug & play via USB.
• CONTEG Professional Container Testing System Vacuum-based container testing system that objectively tests sterile container sealing by detecting air leakage through defects. Automatically compares measurements against preset tolerance limits and displays OK (green) or NIO (red) status. Tests containers quickly and reproducibly before sealing and sterilization. Deployed internationally in 8 countries.
• Single-Use Surgical Instruments Disposable surgical instruments including standard instruments, ophthalmology, ENT (HNO), and gynecology instruments. CE marked with sterile packaging, produced in the company's own cleanroom facility in Germany with capacity of up to 90,000 instruments per week.
• VacioPak VAPA500 Vacuum Storage and Transport Packaging System Vacuum storage and transport packaging system that detects even the smallest micro-damage to sterile goods packaging. Includes sealing device, adjustable packing table (DIN or ISO baskets), and vacuum unit with automatic start. Used in hospital sterile supply workflows.
• AutoSteam Steam Cleaner Steam cleaner for internal and external instrument cleaning with accessories. Part of the comprehensive range of steam cleaners and brushes for medical instrument reprocessing in hospital AEMP/CSSD departments.
• MultiSteam Steam Cleaner Multi-purpose steam cleaner for medical instrument cleaning. Part of comprehensive steam cleaning range including brushes for internal and external cleaning.
• MaxiSteam Steam Cleaner Large-capacity steam cleaner for instrument cleaning. Part of comprehensive steam cleaning solutions for medical device reprocessing.
• SteamBox Steam Cleaning Workstation Steam cleaning work station solution developed with FAMI for the Brazilian market. Integrates controlled steam cleaning as complementary support for safe and effective instrument cleaning processes in an ergonomic workplace solution.
• Helix Test System Single-use indicator strips with self-adhesive backing for documentation, validated for up to 250 uses. Conforms to ISO 11140-1 (Class 6) and PCD according to EN 867-5. Batch control system for steam sterilization processes in loaded autoclaves.
• Bowie & Dick Test Steam penetration and air removal test for vacuum sterilizers, conforms to EN ISO 11140-1 and EN ISO 11140-4 (Class 2+4). Daily steam penetration test with indicator changing from pink to black.
• Ink Test Easy Seal seam tightness test for routine verification of seal seams according to DIN EN ISO 11607-1 Annex B and ASTM F1929. Detects irregularities in weld seams immediately after emptying disposable bottle. TRITON X free.
• Seal Test Daily seal test for functional assessment (OQ) according to DIN EN ISO 11607-2. Used for verifying continuous seal seam with minimum width of 6mm. Inserted into bag or tube and sealed with device for visual control.
• Class 5 Indicators Class 5 indicators for steam sterilization according to ISO 11140-1. Single-use process challenge devices for monitoring sterilization cycles in hospital AEMP/CSSD departments.
• Wash Test Test system for verifying proper cleaning of instruments during washer-disinfector cycles. Used in hospital AEMP/CSSD departments for cleaning process validation.
• Maintenance, Calibration and Validation Services Professional maintenance service including replacement of wear parts, visual inspection, and function testing. Seal parameters (temperature, contact pressure, feed speed) measured and calibrated for complete initial validation and annual performance review. Validation services conducted per DGSV guideline for packaging processes per DIN EN ISO 11607-2:2020.
• Fixation Systems (Fixiersysteme) Silicone elements and rail systems for safe fixation and protection of instruments during transport, cleaning, and sterilization. Silicone elements available in many dimensions, rails in different lengths for all sieve types.
• Surgical Instrument Sieves and Baskets Surgical instrument baskets with round wire bottoms for optimal drainage of rinse water and best drying results. Available in various dimensions with custom sizes possible.
• Roller Holders (Rollenhalter) Roller holder for safe storage of sterile goods packaging rolls with injury-proof cutting head with circular blade. Made of aluminum and powder-coated metal, suitable for wall mounting or table placement.
• Instrument Cleaning Brushes (Bürsten) Comprehensive range of brushes for internal and external cleaning of medical instruments. Includes steam brushes and various brush types for different applications.

Quantifiable outcome

• Container seal defects detected automatically before sterilization - preventing non-sterile instruments from reaching patients
• +4 more outcomes

Named customers5 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration4 records

Feature7 records

Partnerships

Twelve partnerships are on record, tiered core and minor.

• FAMI (Brazil)coreChannel Partner/ Reseller/ DistributorFAMI serves as Entrhal's Brazilian distribution partner. The partnership combines German technology with Brazilian market understanding. FAMI provides technical partnership to hospitals, AEMPs, and surgical centers. Notably, FAMI developed the SteamBox locally in Brazil, adapting Entrhal's Steamer technology for Brazilian AEMP workflows and demonstrating the collaborative innovation between the companies.
• KaikoMedi (Finland)coreChannel Partner/ Reseller/ DistributorKaikoMedi is Entrhal's long-term Finnish distribution partner, specializing in heat sealing devices and new testing equipment for the Finnish market. The partnership has successfully delivered large hospital projects including TYKS T2 Central Hospital (~20 devices), HUS Jorvi Central Hospital (>20 devices), and Päijät-Häme Central Hospital (>10 devices).
• Surgical Holdings (UK)coreChannel Partner/ Reseller/ DistributorSurgical Holdings serves as the UK distribution partner for CONTEG Container Testing System, distributing the product in Great Britain as part of Entrhal's international partner network for objective container seal testing solutions.
• Hallmark Surgical (New Zealand)coreChannel Partner/ Reseller/ DistributorHallmark Surgical distributes the CONTEG Container Testing System in New Zealand, representing Entrhal's international reach in the Oceania region for sterile container seal verification technology.
• AEKA Medical (Malaysia)coreChannel Partner/ Reseller/ DistributorAEKA Medical serves as the Malaysian distribution partner for CONTEG Container Testing System, representing Entrhal in Southeast Asia for objective container seal testing.
• Caster (Hong Kong)coreChannel Partner/ Reseller/ DistributorCaster distributes the CONTEG Container Testing System in Hong Kong, supporting Entrhal's presence in the Asian market for sterile supply quality assurance solutions.
• Beijing M&B Electronic Instruments (China)coreChannel Partner/ Reseller/ DistributorBeijing M&B Electronic Instruments serves as the Chinese distribution partner for the CONTEG Container Testing System, representing Entrhal in mainland China for objective container seal testing solutions.
• Muranaka Medical Instruments (Japan)coreChannel Partner/ Reseller/ DistributorMuranaka Medical Instruments distributes the CONTEG Container Testing System in Japan, bringing Entrhal's sterile container testing technology to the Japanese medical device market.
• Heaton Instrumedics (Australia)coreChannel Partner/ Reseller/ DistributorHeaton Instrumedics has partnered with Entrhal since 2009/2010, distributing DIATEG isolation testers, heat sealing devices, seal tests, and silicone padding mats in Australia. The partnership has made DIATEG probably the most popular isolation tester in Australian CSSDs. Regular personal exchanges and joint trade show presence demonstrate the deep partnership.
• Zign Medical B.V. (Netherlands)coreStrategic or Co-development PartnerZign Medical B.V. became a cooperation partner in 2017. Entrhal Medical B.V. was founded in the Netherlands in 2018, and subsequently acquired a share of Zign Medical B.V., establishing a strategic partnership for product development and market presence in the Benelux region.
• Entrhal Medical B.V. (Netherlands)coreStrategic or Co-development PartnerSubsidiary founded in the Netherlands in 2018. Subsequently acquired partial stake in Zign Medical B.V., creating integrated European operations and expanding market presence in the Benelux region.
• CaritasminorImplementation/ SI/ Consulting PartnerEntrhal cooperates with Caritas for cleanroom operations. Trained Caritas personnel support work in and before the cleanroom, contributing to high hygiene, quality, and process requirements. This partnership combines professional competence with social engagement as part of Entrhal's cleanroom concept.

Scale indicators5 records

Recent moves10 records

Expansion highlights5 records

Market position

Strengths5 records

Weaknesses4 records

Competitive moat5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/entrhal-medical-gmbh

Compliance8 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Subsidiaries1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about ENTRHAL MEDICAL GmbH