Skip to content

Wpk-002

by Hebei Blue Bio Technology CO., Ltd.

Ref WPK-002Model CFL-AL3C/HC20/7E7/7E5/7E6/7E4/3P67/3P65SS/3P65/3P66/ 3P67/C7E6-A/C7E6-S/C7E7-S/BKFC-6F24/LSL/LSC/AKFC-6F21/GCL-SADT/SAFR/SBDT/AKFC-6F22/ GCL-GPDT/GPFR/GCL-AKDT(HD)/AKFR(HD)/AKFC-6F23/GCL-ELDT/ELFR/GCL-VSDT,etc

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697869403ProstheticEH Basic UDI-DI 06978694030242UDI-DIDate27 Apr 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
CFL-AL3C/HC20/7E7/7E5/7E6/7E4/3P67/3P65SS/3P65/3P66/ 3P67/C7E6-A/C7E6-S/C7E7-S/BKFC-6F24/LSL/LSC/AKFC-6F21/GCL-SADT/SAFR/SBDT/AKFC-6F22/ GCL-GPDT/GPFR/GCL-AKDT(HD)/AKFR(HD)/AKFC-6F23/GCL-ELDT/ELFR/GCL-VSDT, etc, WPK-002
Primary DI / UDI-DI
06978694030242
Basic UDI-DI
697869403ProstheticEH
EMDN Code
Y0699 External prostheses and orthoses - other
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000047765
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Hebei Blue Bio Technology CO., Ltd.

See all devices from Hebei Blue Bio Technology CO., Ltd. →

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No