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hot cold pack

by Anhui Kamt Ice Pack Co., Ltd. 19 variants

Ref PTB-6550

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 Number697530662Hotcoldpack59 Basic UDI-DI 06975306620532UDI-DIDate6 Jun 2022RegisteredStatusActive

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  • Withdrawn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
hot cold pack
Model / Reference
PTB-6550
Primary DI / UDI-DI
06975306620532
Basic UDI-DI
697530662Hotcoldpack59
EMDN Code
M9001 Cryotherapy and thermotherapy devices
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000023062
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Anhui Kamt Ice Pack Co., Ltd.

See all devices from Anhui Kamt Ice Pack 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