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Christou1910

by Hebei Denovo Medical Device Co., Ltd 2 variants

Ref CH-009Model CH-012, DN-K31, DN-K32, DN-K33, DN-K34, DN-K35, DN-K36, DN-K37, CH-009, CH-015, DNOR-W01, DNOR-W02, DNOR-W03, DNOR-W04, DNOR-W05, DNOR-W11, DNOR-W12, DNSP-35, DNSP-36, DNSP-37, DNSP-38

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 Number697656807LLB01QH Basic UDI-DI Date21 Jul 2023RegisteredStatusActive

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  • Withdrawn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

Device Name
Lower Limb Brace
Upper Limb Brace
Model / Reference
CH-012, DN-K31, DN-K32, DN-K33, DN-K34, DN-K35, DN-K36, DN-K37, CH-009, CH-015, DNOR-W01, DNOR-W02, DNOR-W03, DNOR-W04, DNOR-W05, DNOR-W11, DNOR-W12, DNSP-35, DNSP-36, DNSP-37, DNSP-38
Primary DI / UDI-DI
06976568071001, 06976568070592
Basic UDI-DI
697656807LLB01QH, 697656807ULB08U2
EMDN Code
Y061299, Y060699
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000035688
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Hebei Denovo Medical Device 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