Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616245

FEI Number

3003408840

Entity Name

GEUDER AG

City/State/Country

HEIDELBERG Baden-Wurttemberg, DE

Establishment Address

HERTZSTRASSE 4, HEIDELBERG Baden-Wurttemberg D-69126, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GEUDER AG (Owner Number: 9024476)

Owner / Operator Contact Address

HERTZSTRASSE 4, --, HEIDELBERG, DE-NOTA 69126, 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
HNK	Probe, Trabeculotomy	Ophthalmic	Class 1	886.4350	1996-09-18
HNE	Snare, Enucleating	Ophthalmic	Class 1	886.4350	1996-09-19
HPN	Magnet, Permanent	Ophthalmic	Class 1	886.4445	1996-09-19
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	1996-09-18
HNJ	Punch, Corneo-Scleral	Ophthalmic	Class 1	886.4350	1996-09-18
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	1996-09-18
HNB	Spoon, Ophthalmic	Ophthalmic	Class 1	886.4350	1996-09-19
HNH	Ring, Ophthalmic (Flieringa)	Ophthalmic	Class 1	886.4350	1996-09-19
HND	Spatula, Ophthalmic	Ophthalmic	Class 1	886.4350	1996-09-18
NCE	Injector, Capsular Tension Ring	Ophthalmic	Class 1	886.4300	2009-06-19
HNC	Specula, Ophthalmic	Ophthalmic	Class 1	886.4350	1996-09-18
NGY	Cannula, Trocar, Ophthalmic	Ophthalmic	Class 1	886.4350	2009-12-16
HOC	Clip, Iris Retractor	Ophthalmic	Class 1	886.4350	1996-09-18
KYG	Device, Irrigation, Ocular Surgery	Ophthalmic	Class 1	886.4360	1997-05-02
HNL	Probe, Lachrymal	Ophthalmic	Class 1	886.4350	1996-09-18
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	1996-09-18
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	1996-09-18
HRH	Trephine, Manual, Ophthalmic	Ophthalmic	Class 1	886.4350	1996-09-18
HLE	Ruler, Nearpoint (Punctometer)	Ophthalmic	Class 1	886.1790	1996-09-18
HNX	Depressor, Orbital	Ophthalmic	Class 1	886.4350	1996-09-18
HOD	Clamp, Eyelid, Ophthalmic	Ophthalmic	Class 1	886.4350	1996-09-19
HOB	Clamp, Muscle, Ophthalmic	Ophthalmic	Class 1	886.4350	1996-09-19

Official Correspondent

No official correspondent registered.

US Agent Details

Melissa Walker Business: Graematter, Inc Email: mwalker@graematter.com Phone: (636) 4057498

Related Public Records

Same Entity

GEUDER AG

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
K871646	Ocular Instruments, Inc.	TANNE CORNEAL CUTTING BLOCK	1987-05-18
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

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3015177648	KATENA PRODUCTS, INC.	Parsippany, NJ, US
3023657851	INKA SURGICAL INSTRUMENTS	Jandakot Western Australia, AU
8040382	PAUL INSTRUMENTS (INDIA)	CALCUTTA West Bengal, IN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616245. Last updated year: 2026. Please use registration number 9616245 when referencing this establishment in official correspondence.