Hot and cold compress

Ref HOT COLD COMPRESS K1RX-TED-01Model HOT COLD PACK, HOT COLD PAD, COLD PACK, COLD GEL PACK, GEL PACK, ICE PACK, GEL ICE PACK, HOT COLD THERAPY, HOT COLD COMPRESS, HOT COLD GEL COMPRESS, HOT PACK, HOT AND COLD GEL ICE PACK, COLD AND HOT PACK, 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

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number697901767HACC001N9 Basic UDI-DI 06979017670008UDI-DI	Date18 Aug 2025Registered	StatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name: Hot and cold compress
Model / Reference: HOT COLD PACK, HOT COLD PAD, COLD PACK, COLD GEL PACK, GEL PACK, ICE PACK, GEL ICE PACK, HOT COLD THERAPY, HOT COLD COMPRESS, HOT COLD GEL COMPRESS, HOT PACK, HOT AND COLD GEL ICE PACK, COLD AND HOT PACK, etc, HOT COLD COMPRESS K1RX-TED-01

Primary DI / UDI-DI: 06979017670008
Basic UDI-DI: 697901767HACC001N9
EMDN Code: M9001 Cryotherapy and thermotherapy devices

Device Class: Class I
EU market of registration: Austria

Manufacturer details

EUDAMED SRN: CN-MF-000049183
Authorised representative: SUNGO Europe B.V. NL-AR-000000247

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