Organization name

BIRR Biosciences BV

SRN

NL-MF-000023194

Manufacturer status

Active

3 warnings recorded — scroll inside the panel to see all entries.

• Consult instructions for use
• Do not re-use
• Do not use if package is damaged

Primary placement in Belgium; available across 16 countries total.

Trade name

ICSI Dish

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

08717973713524

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

87179737103YQ

Reference / catalog number

1131-ICSI

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

10

Additional product description

ART Dish is intended for preparing and culturing gametes or embryos for use in assisted reproduction techniques (ART).

Additional information URL

https://birr.nl/ifu/

Clinical sizes

No clinical sizes registered for this device.

1 packaging level registered — each level carries its own UDI-DI.

• 08717973713524× 10 unitsBase unit
  • 08717973713531× 24 units

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• U080206CULTURE PLATES FOR ASSISTED REPRODUCTION

• Class IIa medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.