Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010694

FEI Number

4324

Entity Name

Amann Medical GmbH & Co. KG

City/State/Country

Emmingen-Liptingen Baden-Wurttemberg, DE

Establishment Address

NEUHAUSER STRASSE 43, Emmingen-Liptingen Baden-Wurttemberg 78576, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Amann Medical GmbH & Co. KG (Owner Number: 10037037)

Owner / Operator Contact Address

Neuhauser Str. 43, Liptingen, DE-BW 78576, 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
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	2011-06-09
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	2011-06-09
HNI	Retractor, Ophthalmic	Ophthalmic	Class 1	886.4350	2011-06-09
HNZ	Curette, Ophthalmic	Ophthalmic	Class 1	886.4350	2011-06-09
HRH	Trephine, Manual, Ophthalmic	Ophthalmic	Class 1	886.4350	2011-06-09
HLF	Device, Measuring, Lens Radius, Ophthalmic	Ophthalmic	Class 1	886.1430	2011-06-09
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2011-06-09
HOB	Clamp, Muscle, Ophthalmic	Ophthalmic	Class 1	886.4350	2011-06-09
HNC	Specula, Ophthalmic	Ophthalmic	Class 1	886.4350	2011-06-09
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2011-06-09
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2011-06-09
HND	Spatula, Ophthalmic	Ophthalmic	Class 1	886.4350	2011-06-09

Official Correspondent

Juergen Amann

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

Amann Medical 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
K854401	Microsurgical Technology, Inc.	THE NEW MOBILE TIP MCINTYRE CANNULA	1985-12-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0011-2019	Ellex iScience, Inc.	1	ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
Z-0022-2009	Becton Dickinson and Company	1	BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.

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9616972	TITAN SURGICAL	KAZAN Tatarstan, RU
3006677911	Crestpoint Management Ltd.	Crestwood, MO, US
3006541044	Asuzna	Sialkot Punjab, PK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010694. Last updated year: 2026. Please use registration number 8010694 when referencing this establishment in official correspondence.