EDTA.K2, 6ml
by Jiangxi Exquisite Technology Co., Ltd. China EUDAMED
Ref B02K2006Model Plain tube (No Additive), EDTA.K2, EDTA.K2/Gel, EDTA.K3, EDTA.Na2, Sodium Citrate 9NC, Sodium Citrate 9NC /Gel, Sodium Citrate 4NC, etc
EMDN W050101010201
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697656048BCT01KP | Date12 Jan 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Blood Collection Tube For Single-Use
- Model / Reference
- Plain tube (No Additive), EDTA.K2, EDTA.K2/Gel, EDTA.K3, EDTA.Na2, Sodium Citrate 9NC, Sodium Citrate 9NC /Gel, Sodium Citrate 4NC, etc, B02K2006
- Primary DI / UDI-DI
- 06976560480528
- Basic UDI-DI
- 697656048BCT01KP
- EMDN Code
- W050101010201 Blood collection, tubes with additives or serum separator
- Device Class
- Class A
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000038653
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED 2599493d-a8bb-411b-818e-1cd27b5def18