Joyum
by Ningbo Joyum Medical Device Technology Co., Ltd.
Ref Additive-freeModel Additive-free Coagulant Separation gel Separation gel/coagulant EDTA K2 EDTA K3 EDTA Na2 EDTA K2/separation gel 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 | Number697356009DVBCT01T9 16973560090150 | Date12 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- Withdrawn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
- Disposable Vacuum Blood Collection Tube
- Model / Reference
- Additive-free Coagulant Separation gel Separation gel/coagulant EDTA K2 EDTA K3 EDTA Na2 EDTA K2/separation gel etc, Additive-free
- Primary DI / UDI-DI
- 16973560090150
- Basic UDI-DI
- 697356009DVBCT01T9
- EMDN Code
- W050101010201, W050101010202
- Device Class
- Class A
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000008256
- 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