Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010851

FEI Number

6362

Entity Name

BERNHARD FREY

City/State/Country

TUTTLINGEN Baden-Wurttemberg, DE

Establishment Address

BRENNTENSTRASSE 36, TUTTLINGEN Baden-Wurttemberg D-78532, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

BERNHARD FREY (Owner Number: 8010851)

Owner / Operator Contact Address

BRENNTENSTRASSE 36, --, TUTTLINGEN, BADEN-WURTTEMBERG, DE-NOTA D-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
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2014-11-01
KAL	Retractor, Ent	Ear, Nose, Throat	Class 1	874.4420	2004-06-30
HNB	Spoon, Ophthalmic	Ophthalmic	Class 1	886.4350	1987-05-29
HNA	Spud, Ophthalmic	Ophthalmic	Class 1	886.4350	1987-05-29
JYO	Knife, Ear	Ear, Nose, Throat	Class 1	874.4420	1994-02-18
JYJ	Gauge, Measuring	Ear, Nose, Throat	Class 1	874.4420	2014-04-14
EGN	Scissors, Surgical Tissue, Dental	Dental	Class 1	872.4565	1987-07-06
HNZ	Curette, Ophthalmic	Ophthalmic	Class 1	886.4350	2014-11-01
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	1998-07-01
JYL	Hook, Microsurgical Ear	Ear, Nose, Throat	Class 1	874.4420	2014-11-01
KBD	Scissors, Nasal	Ear, Nose, Throat	Class 1	874.4420	1998-02-23

Official Correspondent

No official correspondent registered.

US Agent Details

Angelika Scherp Business: BSI BUSINESS SUPPORT INTERNATIONAL Email: info@bsi-fda.com Phone: (212) 3318358

Related Public Records

Same Entity

BERNHARD FREY

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
K821275	Conphar, Inc.	MAYO SCISSOR STRAIGHT 5 1/2	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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010851. Last updated year: 2026. Please use registration number 8010851 when referencing this establishment in official correspondence.