Vacuum Blood Collection Tubes for single use
by Jiangxi Glance Medical Equipment Co., Ltd.
Ref Plain- PET (3 mL)Model Plain、EDTA K2、EDTA K2/Gel、EDTA K3、EDTA Na2、Sodium citrate 1:9、Sodium citrate 1:9/Gel、Sodium citrate 1:4、Heparin sodium、Heparin sodium/Gel、heparin lithium, 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 | Number697070683GLSVBCT46 06970706830000 | Date6 Aug 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- Withdrawn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
- Plain、EDTA K2、EDTA K2/Gel、EDTA K3、EDTA Na2、Sodium citrate 1:9、Sodium citrate 1:9/Gel、Sodium citrate 1:4、Heparin sodium、Heparin sodium/Gel、heparin lithium, etc, Plain- PET (3 mL)
- Primary DI / UDI-DI
- 06970706830000
- Basic UDI-DI
- 697070683GLSVBCT46
- EMDN Code
- W050101010201, W050101010202
- Device Class
- Class A
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000036336
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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