Question 1

What types of medical devices does STEMA Medizintechnik GmbH manufacture?

Accepted Answer

STEMA Medizintechnik GmbH specializes in reusable surgical instruments, including general-purpose surgical scissors, suturing needle holders, and instrument trays. Their portfolio also covers hand-held retractors and surgical screwdrivers. Additionally, they produce endoscopic tools like line-powered light source units and strabismus scissors, as well as rigid endoscopic biopsy forceps. The company also manufactures ophthalmic and general surgical accessories such as clippers, punches, curets, and containers. These devices are designed for surgical and diagnostic procedures.

Question 2

Where is STEMA Medizintechnik GmbH based?

Accepted Answer

STEMA Medizintechnik GmbH is based in Germany, specifically in Neuhausen ob Eck, near Tuttlingen. The company relocated to its new facility in July 2020.

Question 3

Which regulatory registries list STEMA Medizintechnik GmbH’s devices?

Accepted Answer

STEMA Medizintechnik GmbH’s devices are listed in the EUDAMED database, which is the European Union’s medical device registry. This platform is used to track and provide transparency on medical devices authorized within the EU.

Question 4

How are STEMA Medizintechnik GmbH’s devices classified under EU regulations?

Accepted Answer

All of STEMA Medizintechnik GmbH’s devices fall under EU Class I classification. This classification applies to low-risk medical devices, such as reusable surgical instruments and endoscopic accessories, which are deemed to pose minimal risk to patients and users. Class I devices typically undergo basic conformity assessment procedures before being authorized for market placement.

Device	Model / Reference	Registries	Class	Status
Cables/Leads, Electrosurgical Unit	EK-010-002	EUDAMED	Class I	Active
Punches, Other	MC-002-083-AT	EUDAMED	Class I	Active
Forceps, Grasping, Flexible Endoscopic	AC-016-012	EUDAMED	Class I	Active
Punches, Other	MC-002-055-C	EUDAMED	Class I	Active
Forceps, Other	AC-107-211-T	EUDAMED	Class I	Active
Forceps, Grasping, Flexible Endoscopic	AB-006-044	EUDAMED	Class I	Active
Clamps, Other	ZA-001-293	EUDAMED	Class I	Active
Elevators, Other	LD-100-066	EUDAMED	Class I	Active
Punches, Other	MC-001-115	EUDAMED	Class I	Active
Tenaculums, Other	LD-003-061	EUDAMED	Class I	Active
Retrieval Baskets	AF-001-023	EUDAMED	Class I	Active
Punches, Other	MC-001-114	EUDAMED	Class I	Active
Punches, Other	MC-003-024-C	EUDAMED	Class I	Active
Forceps, Grasping, Flexible Endoscopic	DA-006-051	EUDAMED	Class I	Active
Forceps, Biopsy, Flexible Endoscopic	AC-002-015	EUDAMED	Class I	Active
Punches, Other	BC-387-350-PA	EUDAMED	Class I	Active
Specula, Ear	LF-001-060	EUDAMED	Class I	Active
Containers	FA-110-200-BL	EUDAMED	Class I	Active
Punches, Other	MC-002-026-0T	EUDAMED	Class I	Active
Scoops	ZA-002-591	EUDAMED	Class I	Active
Punches, Other	BC-530-350-PA	EUDAMED	Class I	Active
Punches, Other	MC-002-080-C	EUDAMED	Class I	Active
Clamps, Artery	ZA-001-072	EUDAMED	Class I	Active
Spatulas, Other	ZA-003-249	EUDAMED	Class I	Active
Punches, Other	MC-002-620-TS	EUDAMED	Class I	Active
Scissors, Other	ZA-004-543	EUDAMED	Class I	Active
Containers	FA-110-200-B	EUDAMED	Class I	Active
Scissors, Eye, Iris	ZA-001-730	EUDAMED	Class I	Active
Forceps, Grasping, Flexible Endoscopic	AC-019-012-OT	EUDAMED	Class I	Active
Forceps, Biopsy, Flexible Endoscopic	AC-001-004-T	EUDAMED	Class I	Active
Punches, Other	MC-003-032	EUDAMED	Class I	Active
Punches, Other	BC-293-350-P	EUDAMED	Class I	Active
Clamps, Penile	AJ-003-140	EUDAMED	Class I	Active
Containers	FA-305-100	EUDAMED	Class I	Active
Punches, Other	BC-709-350-SH	EUDAMED	Class I	Active
Dilators, Other	AJ-003-010	EUDAMED	Class I	Active
Punches, Other	MC-002-024-0	EUDAMED	Class I	Active
Needle Holders	EG-003-060	EUDAMED	Class I	Active
Punches, Other	MC-002-643-SC	EUDAMED	Class I	Active
Punches, Other	MC-002-065-AC	EUDAMED	Class I	Active
Punches, Other	MC-002-243	EUDAMED	Class I	Active
Needle Holders	HG-003-023	EUDAMED	Class I	Active
Forceps, Grasping, Flexible Endoscopic	AC-016-012-OT	EUDAMED	Class I	Active
Containers	FA-510-040	EUDAMED	Class I	Active
Forceps, Other	GB-004-007	EUDAMED	Class I	Active
Trays, Instrument	FA-530-040-B	EUDAMED	Class I	Active
Punches, Other	MC-002-076	EUDAMED	Class I	Active
Forceps, Grasping, Flexible Endoscopic	AC-007-012-OH	EUDAMED	Class I	Active
Forceps, Other	LC-020-046	EUDAMED	Class I	Active
Forceps, Grasping, Flexible Endoscopic	AC-009-211	EUDAMED	Class I	Active

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