Access 2 mL Sample Cups
Ref 81902
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number15099590181902T2 | Date6 Apr 2022 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- 81902
- Primary DI / UDI-DI
- 15099590180232, 15099590817152
- Basic UDI-DI
- 15099590181902T2, 15099590981902WA
- EMDN Code
- W05020180 Samples transport, containers - accessories
- Device Class
- Class A
- EU market of registration
- Ireland
Manufacturer details
- EUDAMED SRN
- US-MF-000010288
- Authorised representative
- Beckman Coulter Ireland Inc. IE-AR-000000886
Other devices from Beckman Coulter, Inc.
Properties
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No