Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004705187

FEI Number

3004705187

Entity Name

STEMA MEDIZINTECHNIK GMBH

City/State/Country

Neuhausen Baden-Wurttemberg, DE

Establishment Address

take-off Gewerbepark 74, Neuhausen Baden-Wurttemberg 78579, DE

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

STEMA MEDIZINTECHNIK GMBH (Owner Number: 9065595)

Owner / Operator Contact Address

take-off Gewerbepark 74, --, Neuhausen ob Eck, DE-NOTA 78579, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2004-08-05
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2004-08-05
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2004-08-05
HXB	Probe	Orthopedic	Class 1	888.4540	2004-08-05
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2004-08-05
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2004-08-05
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2004-08-05
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2004-08-05
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2004-08-05

Official Correspondent

MARKUS KRAMER

US Agent Details

Beate Weiss-Krull Business: Beate Weiss-Krull, Attorney at Law Email: bea@weisskrull-law.com Phone: (503) 2340355

Related Public Records

Same Entity

STEMA MEDIZINTECHNIK GMBH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K851170	The Huxley Instrument Corp.	DISSECTING TWEEZER #283-72PCS. SS 410	1985-04-25
K821248	Conphar, Inc.	ROCHESTER PEAN FORCEPS	1982-05-28
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05
K760422	Cutter Laboratories, Inc.	SURGICAL RETRACTOR	1976-08-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Carbon Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0013-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Stainless Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Z-0034-2012	X Spine Systems Inc	1	Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050, Mfr. By: Bradshaw Medical Inc., Kenosha, WI 53144 The Axle Torque Driver Handle is used to lock the set screw into the locking plate.
Z-0039-2018	Teleflex Medical	1	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.

Similar Registrations

Registration Number	Establishment Name	Location
3040389290	HUAIYIN MEDICAL INSTRUMENTS CO., LTD.	Huai an City Jiangsu, CN
3014649053	Sterilance Medical (Suzhou) Inc.	Suzhou Jiangsu, CN
3013557562	CBR ENTERPRISE LIMITED	Hong Kong, HK
3009968482	HU-FRIEDY MFG CO., LLC	Des Plaines, IL, US
3016844398	AG MARKETING & DEVELOPMENT GROUP INC DBA AGMD GROUP	Brampton Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004705187. Last updated year: 2026. Please use registration number 3004705187 when referencing this establishment in official correspondence.