Micro Blood Collection Tube
by Shandong Chengwu Medical Products Factory 20 variants
Ref Clot Activator 0.25ML 8*45MMModel 0.2ml,0.25ml,0.5ml,1ml
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 | Number697390596MBCT01QQ 06973905960776 | Date28 Jul 2023 | 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- Withdrawn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
- Device Name
- Micro Blood Collection Tube
- Model / Reference
- 0.2ml, 0.25ml, 0.5ml, 1ml, Clot Activator 0.25ML 8*45MM
- Primary DI / UDI-DI
- 06973905960776
- Basic UDI-DI
- 697390596MBCT01QQ
- EMDN Code
- W050101010201 Blood collection, tubes with additives or serum separator
- Device Class
- Class A
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000003370
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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Properties
Other properties (10)
- 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
- New Device: No