Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012479318

FEI Number

3012479318

Entity Name

Biovico sp. z o.o.

City/State/Country

Wladyslawowo Pomorskie, PL

Establishment Address

7, Skandynawska Street, Wladyslawowo Pomorskie PL-84-120, PL

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Biovico Sp. z o.o. (Owner Number: 10060839)

Owner / Operator Contact Address

Hutnicza 15B, Gdynia, PL-22 81-061, PL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SyntheCel Dura Repair SyntheCel Dura Repair SyntheCel Dura Repair

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GXQ	Dura Substitute	Neurology	Class 2	882.5910	2022-03-31
GXQ	Dura Substitute	Neurology	Class 2	882.5910	2019-07-01
GXQ	Dura Substitute	Neurology	Class 2	882.5910	2019-07-01

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Biovico Sp. z o.o.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012479318. Last updated year: 2026. Please use registration number 3012479318 when referencing this establishment in official correspondence.