Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009504366

FEI Number

3009504366

Entity Name

A1 MEDICAL GMBH

City/State/Country

Tuttlingen Baden-Wurttemberg, DE

Establishment Address

Lessing Str. 50, Tuttlingen Baden-Wurttemberg 78532, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

a1 medical GmbH (Owner Number: 10095679)

Owner / Operator Contact Address

Lessingstr. 50, Tuttlingen, DE-BW 78532, 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
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	2026-04-14
HNH	Ring, Ophthalmic (Flieringa)	Ophthalmic	Class 1	886.4350	2026-04-14
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2026-04-14
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	2026-04-14
MXY	Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal	Ophthalmic	Class 1	886.4350	2026-04-14
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2026-04-14
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2026-04-14
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2026-04-14
KYG	Device, Irrigation, Ocular Surgery	Ophthalmic	Class 1	886.4360	2026-04-14
HNA	Spud, Ophthalmic	Ophthalmic	Class 1	886.4350	2026-04-14
HND	Spatula, Ophthalmic	Ophthalmic	Class 1	886.4350	2026-04-14
HNW	Dilator, Lachrymal	Ophthalmic	Class 1	886.4350	2026-04-14

Official Correspondent

No official correspondent registered.

US Agent Details

Angelika Scherp Business: Business Support International Email: info@bsi-fda.com Phone: (212) 3318358

Related Public Records

Same Entity

a1 medical 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
K874057	Myocure, Inc.	OPHTHALMIC TIP & BLADE SCALPELS	1987-12-23

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
3007507973	ADLER INSTRUMENT COMPANY	Brooksville, FL, US
1057946	KLS-Martin L.P.	Jacksonville, FL, US
1424478	Merced Medical, Inc.	Scottsdale, AZ, US
3013602181	Blink Medical LTD	Solihull, GB
3006554912	STERIS Deutschland GmBh	Wurmlingen Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009504366. Last updated year: 2026. Please use registration number 3009504366 when referencing this establishment in official correspondence.