Vacuum Blood Collection Tubes For Single Use
by Guizhou Gaoyi Medical Technology Research and Development Co., Ltd. 4 variants
Ref 3mLModel No additive tube:1mL/2mL/3mL/4mL/5mL/6mL/7mL/8mL/9mL/10mL Procoagulant tube: 1mL/2mL/3mL/4mL/5mL/6mL/7mL/8mL/9mL/10mL Separation gel + procoagulant tube:2ml/3ml/3.5ml/4ml/5ml/6ml/7ml/8ml/8.5ml/9ml/10ml etc
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 | Number697585613VBCT01UM 06975856130031 | Date5 Mar 2024 | 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- Withdrawn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
- Vacuum Blood Collection Tubes For Single Use
- Model / Reference
- No additive tube:1mL/2mL/3mL/4mL/5mL/6mL/7mL/8mL/9mL/10mL Procoagulant tube: 1mL/2mL/3mL/4mL/5mL/6mL/7mL/8mL/9mL/10mL Separation gel + procoagulant tube:2ml/3ml/3.5ml/4ml/5ml/6ml/7ml/8ml/8.5ml/9ml/10ml etc, 3mL
- Primary DI / UDI-DI
- 06975856130031
- Basic UDI-DI
- 697585613VBCT01UM
- EMDN Code
- W050101010201, W050101010202
- Device Class
- Class A
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000040205
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Guizhou Gaoyi Medical Technology Research and Development Co., Ltd.
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