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Cell-Free DNA Blood Collection Tube

EUDAMED

Class 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

by Huachenyang (Shenzhen) Technology Co., Ltd.

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 EUDAMED
CY-BCT-P10 EUDAMED
CY-BCT-G10 EUDAMED
CY-BCT-G5 EUDAMED
CY-BCT-P5 EUDAMED

Identifiers

Primary DI / UDI-DI
06974488992048 EUDAMED
06974488992024 EUDAMED
06974488992017 EUDAMED
06974488992031 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

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Manufacturer

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