Vacuum Blood Collection Tubes For Single Use
by Guizhou Gaoyi Medical Technology Research and Development Co., Ltd. 4 variants
Ref 2mL, 4mL, 5mL, 10mL, VT1307501ER, 7mL, 6mL, 1mLModel 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, No additive
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697585613VBCT01UM | Date5 Mar 2024 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Trade Name
- Vacuum blood collection tubes for single use No additive 1ml
- 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, 2mL, 4mL, 5mL, 10mL, No additive, VT1307501ER, 7mL, 6mL, 1mL
- Primary DI / UDI-DI
- 06975856130024, 06975856130048, 06975856130055, 06975856130109, 66920756722208, 06975856130079, 06975856130062, 06975856130017
- Basic UDI-DI
- 697585613VBCT01UM, 69207567ZKZXG00017P
- EMDN Code
- W050101010202, W050101010201
- Device Class
- Class A
- EU market of registration
- AustriaHungary
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 (9)
- 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