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Shoulder brace

by Shijiazhuang aofeite imp&exp co., ltd EUDAMED

Active European Union

Ref H007

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69537519SHOULDERRD Basic UDI-DIDate8 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

NorwayNorwayIcelandNorwaySwedenFinlandFinlandNorwaySwedenFinlandFinlandNorwaySwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceLiechtensteinAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalyTürkiyeTürkiyeSpainSpainCroatiaGreeceTürkiyeTürkiyeTürkiyeTürkiyeMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Not drawn on the map: Northern Ireland.

  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Liechtenstein
  • Lithuania
  • Luxembourg
  • Malta
  • Netherlands
  • Northern Ireland
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • Türkiye

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
Shoulder brace
Model / Reference
H007
Primary DI / UDI-DI
06953751918862
Basic UDI-DI
69537519SHOULDERRD
EMDN Code
Y060621 Shoulder orthoses
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000011825
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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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