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Cooling patch

by Tianjin fuqin science & technology Corp., Ltd.

Ref 180mm×59mmModel 65mm×170mm, 180mm×85mm, 95mm×52mm, 180mm×59mm, 50mm×120mm, 85mm×125mm, 100mm×140mm, 160mm×56mm, 235mm×95mm, 96mm×120mm, 132mm×60mm, 12mm×50mm, 15mm×60mm, 30mm×60mm, 35mm×35mm, 35mm×75mm, etc

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 Number69411554CoolingpatchAP Basic UDI-DI 06941155400748UDI-DIDate13 Mar 2024RegisteredStatusActive

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  • Withdrawn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 patch
Model / Reference
65mm×170mm, 180mm×85mm, 95mm×52mm, 180mm×59mm, 50mm×120mm, 85mm×125mm, 100mm×140mm, 160mm×56mm, 235mm×95mm, 96mm×120mm, 132mm×60mm, 12mm×50mm, 15mm×60mm, 30mm×60mm, 35mm×35mm, 35mm×75mm, etc
Primary DI / UDI-DI
06941155400748
Basic UDI-DI
69411554CoolingpatchAP
EMDN Code
M9001 Cryotherapy and thermotherapy devices
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000020692
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Related devices

Category: Hot/cold therapy pack, reusable

Other devices from Tianjin fuqin science & technology Corp., 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