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prosthetic parts

by Ge Rui Hong Kang Medical Technology(SanHe) Co., Ltd 263 variants

Ref JD-07Model CHG-01,CHG-02,CHG-03,CHG-05,CHG-06,CHG-09,K09,K13AL,K15AL,K16AL,K17AL,K18AL,K19AL,K20AL,CHG-10,CHG-11,CHG-12,CHG-13 CHL-01,CHL-02S,CHL-03,CHL-04,CHL-05S,CHL-06,CHL-06A,CHL-07,CHL-07A,CHL-08,CHL-09,CHL-09A,CHL-10AS,CHL-10,CHL-11, 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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697831171ProstheticZK Basic UDI-DIDate25 Feb 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No notified-body 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  • Withdrawn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

Device Name
prosthetic parts
Model / Reference
CHG-01, CHG-02, CHG-03, CHG-05, CHG-06, CHG-09, K09, K13AL, K15AL, K16AL, K17AL, K18AL, K19AL, K20AL, CHG-10, CHG-11, CHG-12, CHG-13 CHL-01, CHL-02S, CHL-03, CHL-04, CHL-05S, CHL-06, CHL-06A, CHL-07, CHL-07A, CHL-08, CHL-09, CHL-09A, CHL-10AS, CHL-10, CHL-11, etc, JD-07
Primary DI / UDI-DI
06978311712230
Basic UDI-DI
697831171ProstheticZK
EMDN Code
Y0699 External prostheses and orthoses - other
Device Class
Class I
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000046610
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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See all devices from Ge Rui Hong Kang Medical Technology(SanHe) 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