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Medical Orthopedic Brace and Support

by Hebei Shengankang Medical Equipment Co., Ltd 234 variants

Ref AK-016Model AK-001、AK-002、AK-003、AK-004、AK-005、AK-006、AK-007、AK-008、AK-009、AK-010、AK-011、AK-012、AK-013、AK-014、AK-015、AK-016、AK-017、AK-018、AK-019、AK-020

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697098594001PZ Basic UDI-DI 06970985941626UDI-DIDate30 Jun 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  • Withdrawn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
AK-001、AK-002、AK-003、AK-004、AK-005、AK-006、AK-007、AK-008、AK-009、AK-010、AK-011、AK-012、AK-013、AK-014、AK-015、AK-016、AK-017、AK-018、AK-019、AK-020, AK-016
Primary DI / UDI-DI
06970985941626
Basic UDI-DI
697098594001PZ
Direct Marketing DI
06970985941626
EMDN Code
V0899 Medical support equipment - other
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000056671
Authorised representative
Humiss Beratung GmbH DE-AR-000023447

Other devices from Hebei Shengankang Medical Equipment Co., Ltd

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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