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B-good

by Wuhan Huawei Technology Co., Ltd

Ref B1011Model Type A/Type B/Type C/Type D

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 Number69452960Coglpatch001V4 Basic UDI-DI 06945296006661UDI-DIDate20 May 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  • Withdrawn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

Device Name
Cooling gel patch
Model / Reference
Type A/Type B/Type C/Type D, B1011
Primary DI / UDI-DI
06945296006661
Basic UDI-DI
69452960Coglpatch001V4
EMDN Code
M9001 Cryotherapy and thermotherapy devices
Device Class
Class I
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000014668
Authorised representative
Humiss International B.V. NL-AR-000001490

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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