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VanGenes
EUDAMEDClass A (EU MDR)
Ref 10 ml (Ordinary type) ZXDNA1001Model Cell free DNA preservative tubes
Identity
- Trade Name
- VanGenes EUDAMED
- Device Name
- Vacuum Blood Collection System EUDAMED
- Model / Reference
- Cell free DNA preservative tubes EUDAMED10 ml (Ordinary type) ZXDNA1001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16975516220000 EUDAMED
- Basic UDI-DI
- 697551622CFDNA100501Z9 EUDAMED
- EMDN Code
- W050101010201 BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
VanGenes by Xiamen Zhixuan Biotech Co., Ltd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697551622CFDNA100501Z9 | Class A | Active |
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Manufacturer
- Manufacturer
- Xiamen Zhixuan Biotech Co., Ltd
- EUDAMED SRN
- CN-MF-000027993
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 3397605c-e6bb-4937-a11a-2026ab2e5cc4 61 fields · synced Jun 19, 2026