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Cell-Free DNA Collection Tube
EUDAMEDClass A (EU MDR)
Ref T000002Model G Tube,10 mL
Identity
- Device Name
- Cell-Free DNA Collection Tube EUDAMED
- Model / Reference
- G Tube,10 mL EUDAMEDT000002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16974968583404 EUDAMED
- Basic UDI-DI
- 1697496858GTube10mLHV EUDAMED
- EMDN Code
- W050101010201 BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
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
Cell-Free DNA Collection Tube by GeneMind Biosciences 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 | 1697496858GTube10mLHV | Class A | Active |
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Manufacturer
- Manufacturer
- GeneMind Biosciences Co., Ltd.
- EUDAMED SRN
- CN-MF-000025785
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (1)
- EUDAMED 90111c33-8f2a-47fb-bb10-3289191dd6eb 61 fields · synced Jun 17, 2026