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Cell-Free DNA Blood Collection Tube
EUDAMEDClass A (EU MDR)
Ref CY-BCT-P10Model CY-BCT-G5,CY-BCT-G10, CY-BCT-P5,CY-BCT-P10Ref CY-BCT-G10Ref CY-BCT-G5Ref CY-BCT-P5
Identity
- Trade Name
- Cell-Free DNA Blood Collection Tube EUDAMED
- Device Name
- Cell-Free DNA Blood Collection Tube EUDAMED
- Model / Reference
- CY-BCT-G5,CY-BCT-G10, CY-BCT-P5,CY-BCT-P10 EUDAMEDCY-BCT-P10 EUDAMEDCY-BCT-G10 EUDAMEDCY-BCT-G5 EUDAMEDCY-BCT-P5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974488992048 EUDAMED06974488992024 EUDAMED06974488992017 EUDAMED06974488992031 EUDAMED
- Basic UDI-DI
- 697448899CY-F0/0/5/2/6V7T EUDAMED
- EMDN Code
- W050101010201,W050101010202 EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Cell-Free DNA Blood Collection Tube by Huachenyang (Shenzhen) Technology 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 | 697448899CY-F0/0/5/2/6V7T | Class A | Active |
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Manufacturer
- Manufacturer
- Huachenyang (Shenzhen) Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000020236
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (4)
- EUDAMED 8fb31a2b-733b-4278-a190-e137fe3aca0b 61 fields · synced Jul 26, 2026
- EUDAMED b36ad2e7-385c-42b0-89f7-86428b961b53 61 fields · synced May 17, 2026
- EUDAMED b82719b1-9cb6-4756-8e07-b32ab91a3145 61 fields · synced May 18, 2026
- EUDAMED ffe3a9f1-2f9f-4403-810f-4c467b56e916 61 fields · synced May 18, 2026