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Back Brace

by Cofoe Medical Technology Co., Ltd. 7 variants

Ref NL1/M码Model AP1, U9, BQ1, NL1, NE1, K2, S1, BE1, BU9, B3, B4, B5, B6, B7, C1, C2, C3, C4, C5

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69507155BBD8 Basic UDI-DI 06950715507117UDI-DIDate22 May 2025RegisteredStatusActive

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  • Withdrawn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
AP1, U9, BQ1, NL1, NE1, K2, S1, BE1, BU9, B3, B4, B5, B6, B7, C1, C2, C3, C4, C5, NL1/M码
Primary DI / UDI-DI
06950715507117
Basic UDI-DI
69507155BBD8
EMDN Code
Y060699 Orthoses, upper extremity - other
Device Class
Class I
EU market of registration
Northern Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000001077
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Other devices from Cofoe Medical Technology Co., Ltd.

See all devices from Cofoe Medical 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