Round Bottom Tube 5 ml

Organization name

BIRR Biosciences BV

SRN

NL-MF-000023194

Manufacturer status

Active

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

• Contains a medicinal substance
• Do not re-use
• Do not use if package is damaged

Primary placement in Belgium; available across 13 countries total.

Trade name

Round Bottom Tube 5 ml

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.

08717973710448

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.

87179737110YM

Reference / catalog number

113516

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

Containers for preparation of biological material for assisted reproduction.

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.

• 08717973710448× 10 unitsBase unit
  • 08717973710509× 180 units

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

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

• U080207CONTAINERS FOR PREPARATION OF BIOLOGICAL MATERIAL FOR ASSISTED REPRODUCTION

• Class IIa medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.