Design, manufacture and distribution of single-use microsurgical instruments and intraocular lenses for cataract surgery.

GEMMA MEDICAL Service GmbH

Pforzheim · Brügg BE · MannheimNew on Amplifa

2–10Employees (Gemma Medical AG)

3Locations in DE and CH

ISO 13485:2016Certified according to

Class IIa/IIbMedical device classes

About Gemma Medical

GEMMA MEDICAL Service GmbH is a medical device manufacturer based in Pforzheim, specialized in ophthalmology. The company develops, manufactures and distributes single-use microsurgical instruments, surgical accessories and intraocular lenses (IOLs) for cataract surgery. Production is carried out using its own modern manufacturing technologies in accordance with the applicable standards for sterile class IIa ophthalmic products and class IIb ophthalmic implants. All products undergo 100% quality control. The corporate network includes Gemma Medical AG in Brügg (Switzerland) and 1stQ GmbH in Mannheim, through which the products are distributed worldwide. The headquarters in Pforzheim also serves as the logistics center for international shipping.

Site: Pforzheim
Processes: Design, manufacture and distribution of intraocular lenses, Manufacture of single-use instruments for ophthalmology, 100% quality control (100% quality control), Design and manufacture of single-use microsurgical instruments, Manufacture of intraocular lenses (IOLs), Surgical accessories, 100% quality control, Logistics center
Materials: Intraocular lenses, Single-use instruments
Certificates: ISO 13485:2016, ISO 13485
Employees: 2–10
Industries: Medical technology, Ophthalmology, Cataract surgery

01
Design and development (R&D)
02
Manufacturing
03
100% quality control
04
Logistics and shipping
05
Worldwide distribution via 1stQ GmbH

Manufacturing and Processes

IOL

Intraocular lenses

Class IIb ophthalmic implants for cataract surgery.

SUI

Single-use instruments

Non-active, non-implantable class IIa instruments for ophthalmic microsurgery.

Locations

Pforzheim

Headquarters and logistics center

Materials: IOL, single-use instruments

Brügg BE

Gemma Medical AG site

Mannheim

Distribution Worldwide (1stQ GmbH)

Products

**Intraocular lenses (IOL)**Class IIb implants · Ophthalmology

**Single-use instruments**Single-use microsurgical instruments · Cataract surgery

Inside the production

Industries

Medical technologyOphthalmologyCataract surgery

Processes & technical limits

Processes	Tolerance	Max. part	Weight	Lot size	Materials
Design, manufacture and distribution of intraocular lensesEngineering	–	–	–	–	–
Manufacture of single-use instruments for ophthalmologyManufacturing (unspecified)	–	–	–	–	–
100% quality control (100% quality control)Testing	–	–	–	–	–

Additional services

Design and manufacture of single-use microsurgical instrumentsManufacture of intraocular lenses (IOLs)Surgical accessories100% quality controlLogistics center

Quality

As a medical device manufacturer, Gemma Medical is certified according to ISO 13485:2016 and applies all relevant standards for sterile class IIa ophthalmic products as well as class IIb ophthalmic implants. All products undergo 100% quality control.

Evidence	Pforzheim
ISO 13485