Labtub
by Lingen Precision Medical Products (Shanghai) Co., Ltd. 49 variants
Ref 032406211101Model Clot activator and Separate Gel
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 | Number69736472901ACG0176 06973647290087 | Date25 Nov 2021 | 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- Withdrawn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
- Blood Collection Tubes
- Model / Reference
- Clot activator and Separate Gel, 032406211101
- Primary DI / UDI-DI
- 06973647290087
- Basic UDI-DI
- 69736472901ACG0176
- EMDN Code
- W050101010201 Blood collection, tubes with additives or serum separator
- Device Class
- Class A
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- CN-MF-000014163
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Lingen Precision Medical Products (Shanghai) Co., Ltd.
See all devices from Lingen Precision Medical Products (Shanghai) Co., Ltd. →
Properties
Other properties (11)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No