Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9612773

FEI Number

3003888652

Entity Name

Biover AG

City/State/Country

Hergiswil Nidwalden, CH

Establishment Address

Muliweg 2, Hergiswil Nidwalden CH-6052, CH

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Baxter Healthcare Corporation (Owner Number: 9043836)

Owner / Operator Contact Address

Muliweg 2, Hergiswil, CH-NW CH-6052, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Biover microsurgical titanium instruments , tweezers,needle holders,scissors

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2014-09-11

Official Correspondent

Maha Nolasco

US Agent Details

Maha Nolasco Business: Baxter Healthcare Corporation Email: maha_nolasco@baxter.com Phone: (224) 2706181

Related Public Records

Same Entity

Baxter Healthcare Corporation

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-2020	Baxter Healthcare Corporation	2	L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide.
Z-0008-04	Rultract Inc	1	Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9612773. Last updated year: 2026. Please use registration number 9612773 when referencing this establishment in official correspondence.