Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017140490

FEI Number

3017140490

Entity Name

BIRR BIOSCIENCES BV

City/State/Country

Breukelen Utrecht, NL

Establishment Address

Merwedeweg 4 B 7, Breukelen Utrecht 3621 LR, NL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BIRR BioSciences BV (Owner Number: 10075300)

Owner / Operator Contact Address

Merwedeweg 4 B 7, Breukelen, NL-UT 3621 LR, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ART Labware ART Dish

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PUD	Labware, Assisted Reproduction, Exempt	Obstetrics/Gynecology	Class 2	884.6160	2023-12-06
KIZ	Dish, Tissue Culture	Hematology	Class 1	864.2240	2020-06-11

Official Correspondent

Tom Vermeiden

US Agent Details

Craig Hoffmann Business: IVF store Email: craig.hoffmann@ivfstore.com Phone: (470) 6954141

Related Public Records

Same Entity

BIRR BioSciences BV

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 3017140490. Last updated year: 2026. Please use registration number 3017140490 when referencing this establishment in official correspondence.