Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9610557

FEI Number

3002807056

Entity Name

GEORG ALBER GMBH & CO. KG

City/State/Country

RENQUISHAUSEN Baden-Wurttemberg, DE

Establishment Address

LINDENSTR. 13, RENQUISHAUSEN Baden-Wurttemberg 78603, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

GEORG ALBER GMBH & CO. KG (Owner Number: 8010321)

Owner / Operator Contact Address

LINDENSTR. 13, RENQUISHAUSEN, DE-BW 78603, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

18-1800

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	1986-05-26
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-04-27
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2023-06-06
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	1996-07-19
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2012-12-15
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1996-07-03
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	1997-10-02
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	1997-10-02
LWK	Razor, Surgical	General, Plastic Surgery	Class 1	878.4800	1997-04-15

Official Correspondent

GERD ALBER

US Agent Details

ANGELIKA SCHERP Business: BUSINESS SUPPORT INTERNATIONAL Email: info@bsi-fda.com Phone: (212) 3318358

Related Public Records

Same Entity

GEORG ALBER GMBH & CO. KG

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
K874057	Myocure, Inc.	OPHTHALMIC TIP & BLADE SCALPELS	1987-12-23
K851170	The Huxley Instrument Corp.	DISSECTING TWEEZER #283-72PCS. SS 410	1985-04-25
K821248	Conphar, Inc.	ROCHESTER PEAN FORCEPS	1982-05-28

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0026-04	Surgical Specialties Corp	1	Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives.
Z-1922-2024	Alcon Research LLC Aspex Facility	1	20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Z-1923-2024	Alcon Research LLC Aspex Facility	1	ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Z-1924-2024	Alcon Research LLC Aspex Facility	1	ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Z-1925-2024	Alcon Research LLC Aspex Facility	1	ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A

Similar Registrations

Registration Number	Establishment Name	Location
3004571672	Fischer Surgical Inc.	Imperial, MO, US
2431166	Sklar Corporation	West Chester, PA, US
3015895045	Sklar Corporation - Warehouse	Salisbury, MD, US
3009718267	DIVERSITY CORPORATION FZE	Sharjah Ash Shariqah, AE
3013784566	Berger Surgical Medical Products GmbH	Neuhausen ob Eck Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9610557. Last updated year: 2026. Please use registration number 9610557 when referencing this establishment in official correspondence.