← Back to catalogue
VanGenes
EUDAMEDClass A (EU MDR)
Ref 5 ml (Ordinary type) ZXDNA0501Model Cell free DNA preservative tubesRef 5 ml (Ordinary type) ZXDNA0501Ref 10 ml (Ordinary type)
Identity
- Trade Name
- VanGenes EUDAMED
- Device Name
- Vacuum Blood Collection System EUDAMED
- Model / Reference
- Cell free DNA preservative tubes EUDAMED5 ml (Ordinary type) ZXDNA0501 EUDAMED5 ml (Ordinary type) ZXDNA0501 EUDAMED10 ml (Ordinary type) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16975516220031 EUDAMED16975516220017 EUDAMED16975516220024 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
- France EUDAMEDItaly EUDAMEDGermany 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Xiamen Zhixuan Biotech Co., Ltd
- EUDAMED SRN
- CN-MF-000027993
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED 65daf072-3363-4a49-bc64-d7636e794ec8 61 fields · synced Jul 21, 2026
- EUDAMED 8ce7fdc6-c872-400b-b861-a073ca4f9ac7 61 fields · synced May 19, 2026
- EUDAMED 24a14366-22bc-41f1-a73e-aaab7a8d6ac7 61 fields · synced May 19, 2026