Hygcen Germany Gmbh

What Hygcen Germany Gmbh does

HygCen Germany GmbH is an accredited microbiological testing laboratory headquartered in Schwerin, Germany, specializing in disinfectant efficacy, biocompatibility, and reprocessing validation for medical device manufacturers, disinfectant producers, and processing equipment makers. Founded on March 7, 1996 by Prof. Dr. med. Heinz-Peter Werner, the family-owned GmbH employs approximately 70 staff and serves more than 650 clients globally. The laboratory operates under DAkkS accreditation per DIN EN ISO/IEC 17025 (registration D-PL-18818-02), GLP compliance, and ZLG recognition, positioning it as a credentialed provider of regulatory-grade hygiene testing within the EU compliance ecosystem.

The service portfolio spans disinfectant efficacy testing under EN 14885, EN 14476, and EN 17272; biocompatibility assessment per ISO 10993; reprocessing validation against ISO 17664, ISO 15883, and ISO 17665; type testing of processing equipment; antimicrobial activity testing per ISO 22196; and contract R&D. Technical infrastructure includes EN 17272-compliant test rooms of 4m³ and 75m³ capacity, animal-free testing methodologies, and QES-signed digital test reports. The business model is B2B professional services with quote-based, pay-as-you-go project pricing; revenue is not publicly disclosed and the company has raised no external capital.

The leadership team comprises Dr. med. univ. Sebastian Werner (Managing Director / second-generation owner since 2013), Dr. rer. med. Claudia Hildebrandt (Department Director, Microbiological Testing), Dipl.-Ing. Christian Lösche (Department Director, Medical Devices), Dr. rer. nat. Oliver Riebe (Vice Department Director, Medical Devices), and several division managers covering disinfectant testing, reprocessing, hygiene, and sterile barrier systems. Geographic footprint is concentrated in Germany with claimed international reach through remote client engagement; no foreign offices, partnerships, or distribution agreements have been disclosed.

Name

Hygcen Germany Gmbh

Legal name

HygCen Germany GmbH

Website

https://hygcen.de

Company type

Private

Founded year

1996

Operating status

Operating

Short description

HygCen Germany GmbH is an accredited microbiological testing laboratory in Schwerin, Germany, providing disinfectant efficacy, biocompatibility, and reprocessing validation testing for medical device manufacturers, disinfectant producers, and processing equipment makers.

Ownership category

akta.pro rank

Product category

Medical Device Testing Services

NAICS

Testing Laboratories and Services (541380), Testing Laboratories and Services (54138), Medical Laboratories (621511)

SIC

Services-Testing Laboratories (8734), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Laboratory Quality & GLP/GCLP Compliance (HLAGAKAK)

akta.pro secondary industries

Microbiology & Sterility Assurance (Bioburden/Endotoxin/Sterility) (HLAGADAE), Release Testing & Batch Certification (QC) (HLAGADAC)

Keywords

• Medical device testing
• Disinfectant efficacy testing
• Biocompatibility testing
• Reprocessing validation
• Sterilization validation

Headquarters

HQ city

Schwerin

HQ country

Germany

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Infrastructure, Marketing or Sales

Revenue model

1. Accredited Testing Services: Professional testing services for medical devices and disinfectants. Customers submit products for testing according to EN ISO standards. Revenue generated through testing fees based on scope and complexity of requested tests. Provides digital QES-signed test reports with professional scientific assessment.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels1 record

Core offering

HygCen Germany GmbH operates an accredited testing laboratory (DIN EN ISO/IEC 17025) providing quality assurance testing services for medical devices, disinfectants, and related products. Services span biocompatibility testing (ISO 10993 series), reprocessing validation (ISO 15883, ISO 17664, ISO 17665), sterilization validation, packaging validation (ISO 11607-2), and disinfectant efficacy testing (EN 14476, EN 14885, EN 17272). Customers submit products for laboratory testing and receive QES-signed digital test reports with professional scientific assessment under GLP compliance.

Product overview

HygCen Germany GmbH is an accredited testing laboratory (DIN EN ISO/IEC 17025) providing comprehensive quality assurance testing services for medical devices, disinfectants, and related products. The company operates as a single unified service platform offering multiple interconnected testing services organized around three core areas: (1) Disinfectant Testing covering virucidal activity (EN 14476), general efficacy (EN 14885), and aerogenic surface disinfection (EN 17272); (2) Medical Device Reprocessing Validation including manufacturer specification validation (ISO 17664), cleaning & disinfection validation (ISO 15883), sterilization validation (ISO 17665-1), cleanliness verification (ISO 19227), and packaging/sterile barrier validation (ISO 11607-2); and (3) Biocompatibility Testing under the ISO 10993 series including chemical characterization, cytotoxicity, sensitization, irritation, genotoxicity, hemocompatibility, and pyrogenicity testing. Additional services include type testing of processing equipment, antimicrobial activity testing (ISO 22196), and research & development support for innovative technologies. All services provide QES-signed digital test reports with professional assessment and operate under GLP compliance.

Differentiator

Problem solved

Functional benefit

Products and services

• Disinfectant Testing (EN 14885) Efficacy testing of disinfectants according to European (EN) and international (ISO) standards to ensure compliance with complex biocidal product regulations. For disinfectant manufacturers seeking regulatory compliance.
• Virucidal Activity Testing (EN 14476) Testing to determine the virucidal efficacy of disinfectants against viruses according to EN 14476 standard. For disinfectant manufacturers needing virucidal claim validation.
• Reprocessing of Medical Devices Comprehensive testing services covering the entire reprocessing cycle of medical devices, including validation of manufacturer specifications (ISO 17664), cleaning and disinfection validation (ISO 15883), and sterilization validation (ISO 17665-1). For medical device manufacturers.
• Biocompatibility Testing (ISO 10993 Series) Complete biocompatibility testing suite including biological evaluation (ISO 10993-1), sample preparation (ISO 10993-12), chemical characterization (ISO 10993-18), skin sensitization (ISO 10993-10), cytotoxicity (ISO 10993-5), irritation (ISO 10993-23), genotoxicity (ISO 10993-3), hemocompatibility (ISO 10993-4), and pyrogenicity/endotoxin testing (ISO 10993-11). For medical device manufacturers requiring biological evaluation.
• Type Testing of Processing Equipment Neutral, accredited testing to determine whether reprocessing devices (washer-disinfectors, sterilizers, sealing devices) meet requirements for design, performance, safety, and functionality according to relevant EN standards. For manufacturers of reprocessing equipment.
• Aerogenic Surface Disinfection Testing (EN 17272) Efficacy testing and validation of automated room disinfection processes for airborne disinfection of non-porous surfaces, including bactericidal, mycobactericidal, sporicidal, fungicidal, yeasticidal, virucidal, and phage activity claims. Conducted in dedicated test rooms (4m³ and 75m³ volumes) according to EN 17272 standard.
• Antimicrobial Activity Testing (ISO 22196) Measurement of antibacterial activity on plastics and other non-porous surfaces according to ISO 22196, including antiviral activity testing (ISO 21702) for plastics and textile products (ISO 18184). For manufacturers of antimicrobial materials and products.
• Research and Development Services Innovative testing method development, validation of complex disinfection and sterilization processes, and assessment support for innovative technologies such as UV-C and cold plasma, including collaborations with academic and industry partners.
• Packaging and Sterile Barrier Validation (ISO 11607-2) Validation of sterile packaging processes and sterile barrier systems according to ISO 11607-2, EN 868-6, and ASTM methods including seal integrity, microbial barrier, and aging tests. For medical device manufacturers.
• Cleanliness Verification and Cleaning Validation (ISO 19227)

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

One partnership is on record.

• Qualified External Toxicology PartnerssupportingOthersCoordinates with qualified external toxicology laboratories for ISO 10993-11 systemic toxicity testing when required as part of biological evaluation. Also coordinates chemical characterization (ISO 10993-18) through qualified analytical partners using GC-MS, LC-MS/MS, and ICP-MS. HygCen manages interfaces and remains single point of contact for clients.

Scale indicators5 records

Recent moves8 records

Expansion highlights4 records

Broad incumbents

• Eurofins Scientific: Eurofins is the world's largest testing services group with broad medical device, pharmaceutical, and disinfectant testing capabilities across multiple geographies. Compares to HygCen on accreditation-driven lab testing for regulated products, but operates at vastly larger scale and broader portfolio.
• SGS SA: SGS is a global testing, inspection, and certification company with healthcare and life sciences testing including medical device and disinfectant services. Overlaps with HygCen on accredited product testing, but SGS serves a much broader industry base worldwide.
• Bureau Veritas: Bureau Veritas is a global testing, inspection, and certification company with healthcare and consumer product testing including disinfectant efficacy. Comparable to HygCen on testing services for regulated industries, though with much broader scope.
• TÜV Rheinland: TÜV Rheinland is a major German testing and certification body offering medical device testing, biocompatibility assessment, and disinfection validation. Comparable to HygCen on regulatory-driven testing services for European manufacturers, though at much larger scale.
• TÜV SÜD: TÜV SÜD is a German-based testing and certification giant with medical device testing, biocompatibility, and sterilization services. Most direct European incumbent peer to HygCen given shared German regulatory expertise and MDR-focused testing offerings.
• Intertek: Intertek provides global testing, inspection, and certification with healthcare-focused medical device, pharmaceutical, and antimicrobial testing. Comparable to HygCen on accredited lab services but with broader industry coverage and global footprint.

Direct peers

• NAMSA: NAMSA is the largest dedicated medical device testing CRO, offering biocompatibility (ISO 10993), sterilization validation, and reprocessing testing. Closely comparable to HygCen in service scope and target customer base of medical device manufacturers.
• Nelson Labs (Sotera Health): Nelson Labs is a leading medical device and pharmaceutical testing laboratory specializing in sterility, biocompatibility, and packaging validation per ISO 10993, 11737, and 11607. Highly comparable to HygCen on technical service overlap and target customers.

Emerging players

• WuXi AppTec: WuXi AppTec is a global CRO/CDMO with biocompatibility, medical device testing, and laboratory services capabilities. Comparable to HygCen on regulated life-sciences testing, though WuXi's scale and geographic footprint significantly exceed HygCen's.
• Charles River Laboratories: Charles River's Endotoxin and Microbial Detection division offers sterility, endotoxin, and bioburden testing for medical devices and pharmaceuticals. Partially comparable to HygCen's ISO 11737 and ISO 10993-11 endotoxin services, though Charles River's broader portfolio skews toward pharmaceuticals.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/hygcen-gmbh-centrum-f-r-hygiene-und-medizinische-produktsicherheit

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles14 records

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 Hygcen Germany Gmbh