MEDI-LINE

What MEDI-LINE does

MEDI-LINE is a Belgian medical device contract manufacturer (OEM) founded in 1994 and headquartered in Angleur, near Liège, Belgium. The company specializes in plastic medical devices produced through extrusion and injection molding, operating two clean rooms certified to ISO 7 and ISO 8 standards under EN ISO 13485:2016. Its customer base includes major healthcare OEMs such as Johnson & Johnson (Ethicon Gynecare), for whom it manufactures TVT devices; GE Healthcare, for whom it produces Fastlab cassettes; and TRASIS, for whom it produces cartridges. The company also serves medical device start-ups and research institutions, including CHU de Liège.

The company's revenue model is B2B OEM contract manufacturing, with pricing tied to unit volumes, tooling, and process complexity per regulated device specifications. In addition to contract manufacturing, MEDI-LINE has developed its own proprietary product line, notably the TOM-Sling for male urinary incontinence, co-developed with CHU de Liège. In 2024-2025, the company completed a €3.5 million factory expansion, nearly sixfold increasing its production footprint from 600m² to 3,500m² to scale clean room capacity.

MEDI-LINE has been privately held since October 2019, when CEO Stéphane Semmeling became sole owner. Co-founder Henri Decloux continues as Operations Director. The company has secured international accreditation, including Japan in 2014, and participates in research consortia such as CARDIAX (2016), which support both technology development and market access.

Name

MEDI-LINE

Legal name

MEDI-LINE s.a.

Website

https://mediline.be

Company type

Private

Founded year

1994

Operating status

Operating

Headcount range

11–50 employees

Short description

MEDI-LINE is a Belgian OEM contract manufacturer specializing in plastic medical devices through extrusion and injection molding, serving major healthcare OEMs including Johnson & Johnson, GE Healthcare, and TRASIS via certified clean room operations.

Ownership category

akta.pro rank

Product category

Contract Medical Device Manufacturing

NAICS

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

SIC

Surgical & Medical Instruments & Apparatus (3841), Orthopedic, Prosthetic & Surgical Appliances & Supplies (3842)

akta.pro primary industry

Parenteral & Injectable Packaging Components (Stoppers, Seals, Syringes, Cartridges) (IMALAIAE)

akta.pro secondary industry

Pharmaceutical & Medical Plastic Packaging Manufacturing (IMANAEAK)

Keywords

• Medical device manufacturing
• Plastic extrusion services
• Clean room assembly
• Injection molding medical
• OEM medical devices

Headquarters

HQ city

ANGLEUR (Belgique)

HQ country

Belgium

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Operations, Infrastructure, Technology or R&D, Supply Chain

Revenue model

1. OEM Contract Manufacturing: Contract manufacturing services for medical device companies. MEDI-LINE designs and manufactures medical plastic devices on behalf of pharmaceutical and medical device companies under OEM arrangements. Services include extrusion, injection, clean room assembly, and regulatory support through CE marking.
2. Proprietary Medical Devices: Development and manufacturing of proprietary medical devices including TOM-Sling for male urinary incontinence treatment and potentially other niche medical products targeting the urology and radiopharmacy sectors.
3. Development & Engineering Services: R&D support for start-ups and spin-offs including product development, materials selection, procedure validation, CE dossier preparation, and innovative design services for medical devices.

Go-to-market motion2 records

Distribution channels2 records

Marketing channels5 records

Core offering

MEDI-LINE is a Belgian plastic medical device manufacturer that produces OEM parts and finished medical devices for healthcare and pharmaceutical companies. It offers plastic extrusion, injection molding, and clean room assembly services, alongside proprietary products such as the TOM-Sling, and supports clients through ISO 13485-certified quality systems and CE marking.

Product overview

MEDI-LINE is a manufacturer of medical plastic devices serving exclusively the medical and pharmaceutical sectors. The company operates as an OEM (Original Equipment Manufacturer) providing a portfolio of specialized products including the TOM-Sling device for male urinary incontinence, TVT treatment devices for female urinary incontinence (for Ethicon Gynecare/Johnson & Johnson), Fastlab cassettes for radiopharmacy (for GE Healthcare), and cartridges for radiopharmacy (for TRASIS). The company offers manufacturing capabilities in extrusion (producing tubes from 0.25mm diameter including multi-layer tubing and multi-lumen catheters) and injection molding, all performed in validated clean room environments (ISO 7 and ISO 8). Services span from product idea through CE marking, supporting startup and spin-off companies in developing innovative medical devices.

Differentiator

Problem solved

Functional benefit

Products and services

• TOM-Sling Proprietary medical sling device developed, manufactured, and marketed by MEDI-LINE for surgical applications.
• Plastic Extrusion Services OEM plastic extrusion manufacturing service for medical device components, supplied to healthcare and pharmaceutical clients.
• Injection Molding Services OEM injection molding service producing medical-grade plastic components and parts for healthcare OEMs.
• Clean Room Assembly ISO-controlled clean room assembly service for medical devices and components, offered to OEM clients in healthcare and pharmaceuticals.
• Fastlab Cassettes Plastic cassettes manufactured for radiopharma OEM clients, used in pharmaceutical compounding and radiopharma applications.
• Cartridges (Carpules) Plastic cartridges (carpules) manufactured as OEM components for pharmaceutical delivery and drug packaging applications.
• TVT Devices Plastic TVT (tension-free vaginal tape) medical devices manufactured on an OEM basis for healthcare clients.

Named customers4 records

Segments3 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Seven partnerships are on record, tiered core and minor.

• Stéphane SemmelingcoreOthers · 1 October 2019Current CEO and sole owner of MEDI-LINE since October 2019, taking over from Nexeon Medsystems. Local shareholder with solid business management experience leading the company together with co-founder Henri Decloux.
• CARDIAX Research Consortium (UCL and ULg)minorStrategic or Co-development Partner · 1 January 2016Research program involving Belgian universities (UCL and ULg), Walloon companies, subsidized by Walloon Region. MEDI-LINE selected as OEM partner for developing innovative medical device for screening and monitoring heart disease patients.
• Ethicon Gynecare (Johnson & Johnson)coreOEM/ Whitelabel/ Licensing PartnerMajor OEM customer for whom MEDI-LINE manufactures TVT (Tension-free Vaginal Tape) devices for female urinary incontinence treatment. This represents a core manufacturing relationship with a leading global healthcare company.
• GE HealthcarecoreOEM/ Whitelabel/ Licensing PartnerOEM customer for Fastlab cassettes used in radiopharmacy for medical imaging applications. MEDI-LINE is recognized as an approved supplier through regular audits.
• TRASIScoreOEM/ Whitelabel/ Licensing PartnerOEM customer for cartridges (carpules) for radiopharmacy applications. The partnership involves manufacturing devices for aseptic preparation of individual radiopharmaceutical doses.
• CHU de LiègecoreStrategic or Co-development PartnerAcademic medical center partnership for development of TOM-Sling device for male urinary incontinence treatment. Developed with Professors de Leval and Waltregny, representing a co-development collaboration between industry and academia.
• Henri DeclouxcoreOthersCo-founder and current Operations Director of MEDI-LINE. Working alongside CEO Stéphane Semmeling to lead the company with focus on continuous improvement philosophy and maintaining highest service levels.

Scale indicators7 records

Recent moves7 records

Expansion highlights5 records

Direct peers

• Vygon: French manufacturer of single-use medical devices, particularly catheters and tubing for neonatology, anesthesia, and urology. Similar in offering plastic medical disposables with regulatory compliance expertise, and a direct competitor for OEM catheter and sling manufacturing.
• Flexan: US-based contract manufacturer specializing in custom-molded silicone and thermoplastic components for medical devices, with clean room capabilities. Directly comparable to MEDI-LINE's OEM model serving medical device multinationals.
• Spectrum Plastics Group: Specialty medical plastics manufacturer offering extrusion, injection molding, and clean room assembly for medical OEMs. Operates in the same niche as MEDI-LINE across multiple geographies, with a similar customer mix of OEMs.
• SteriPack: Contract manufacturer of sterile medical devices and packaging for healthcare OEMs, with clean room assembly and regulatory support. Closely comparable in business model — serving as an outsourced manufacturer for leading medical device brands.
• Trelleborg Healthcare & Medical: Division of Trelleborg that manufactures precision polymer and silicone medical components, including tubing and catheters for OEMs. Closely comparable to MEDI-LINE's extrusion and clean room manufacturing focus, but at much larger global scale.

Broad incumbents

• SCHOTT Pharma: Subsidiary of SCHOTT specializing in pharmaceutical primary packaging and drug delivery systems, including syringes, cartridges, and vials. Comparable on the injectable packaging component side of MEDI-LINE's offering, though much broader and larger.
• Gerresheimer: Large German manufacturer of pharmaceutical and medical plastic packaging and devices, including syringes, vials, and prefillable systems. Overlaps with MEDI-LINE's cartridge manufacturing for TRASIS but operates at a much larger global scale across primary packaging.
• West Pharmaceutical Services: Global leader in pharmaceutical elastomer components, seals, and syringes/cartridges for injectable drug delivery. Comparable to MEDI-LINE's cartridge and injection molded component offerings, though at a much larger scale and with broader drug delivery portfolio.
• Teleflex: Diversified medical device company with leading positions in urology (slings, catheters) and other specialties. Comparable to MEDI-LINE on the TVT/TOM-Sling urology side, but operates as a finished medical device company rather than a contract manufacturer.

Regional players

• Bormioli Pharma: Italian pharmaceutical primary packaging manufacturer with products including vials, syringes, and cartridges. Comparable to MEDI-LINE's radiopharmacy cartridge work, though focused more on glass packaging and serving a different European footprint.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• Facebookfacebook.com/MEDI-LINE-418293638379865/?view_public_for=418293638379865
• LinkedInlinkedin.com/company/medi-line

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 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 MEDI-LINE