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Medical Hot Compress

EUDAMED

Class I (EU MDR)

Ref 185mm*80mmModel 96mm*128mmRef Steam eye mask 185*80mmModel Steam eye mask、Warm neck patch、Warm waist patch、Knee patch、Warm foot patch、Moxibustion paste、Hot compress 、Heating pad

by Changzhou Heart Girlfriends Biotechnology Co., Ltd.

Identity

Device Name
Medical Hot Compress EUDAMED
Model / Reference
96mm*128mm EUDAMED
185mm*80mm EUDAMED
Steam eye mask、Warm neck patch、Warm waist patch、Knee patch、Warm foot patch、Moxibustion paste、Hot compress 、Heating pad EUDAMED
Steam eye mask 185*80mm EUDAMED

Identifiers

Primary DI / UDI-DI
06973450210005 EUDAMED
06973450213808 EUDAMED
Basic UDI-DI
697345021MHC01DG EUDAMED
EMDN Code
M0409 DRESSINGS FOR PHOTO- AND THERMOTHERAPY IN THE FORM OF GELS AND SOLUTIONS 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

Medical Hot Compress 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

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Manufacturer

EUDAMED SRN
CN-MF-000036798
Authorised Representative
Sungo Cert GmbH DE-AR-000010869

Sources (2)

  • EUDAMED b1c3761f-046e-4d02-8cf7-972106d265e2 61 fields · synced Oct 6, 2026
  • EUDAMED 406cdff7-7a4c-4e43-98d3-e05a96fc6b68 61 fields · synced Jul 13, 2026