← Back to catalogue

Hydrogel Cold Compress Patch

EUDAMED

Class I (EU MDR)

Ref rectangle 175×65mmModel rectangle：40×40,55×115,60×60,80×60,80×100,100×120,100×140,100×150,150×200,160×55,175×65,200×200,200×300(unit:mm) circle：40×40,60×60,80×80,100×100(unit:mm)

by Changzhou Heart Girlfriends Biotechnology Co., Ltd.

Identity

Device Name
Hydrogel Cold Compress Patch EUDAMED
Model / Reference
rectangle：40×40,55×115,60×60,80×60,80×100,100×120,100×140,100×150,150×200,160×55,175×65,200×200,200×300(unit:mm) circle：40×40,60×60,80×80,100×100(unit:mm) EUDAMED
rectangle 175×65mm EUDAMED

Identifiers

Primary DI / UDI-DI
06973450210609 EUDAMED
Basic UDI-DI
697345021HCCP01BP EUDAMED
EMDN Code
M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Austria EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Hydrogel Cold Compress Patch by Changzhou Heart Girlfriends Biotechnology Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Changzhou Heart Girlfriends Biotechnology Co., Ltd.
EUDAMED SRN
CN-MF-000036798
Authorised Representative
Sungo Cert GmbH DE-AR-000010869

Sources (1)

  • EUDAMED 0f7dfd16-3199-4607-9a6f-0ec364ba6587 61 fields · synced Oct 6, 2026