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Medical Hot Compress
EUDAMEDClass 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
Identity
- Device Name
- Medical Hot Compress EUDAMED
- Model / Reference
- 96mm*128mm EUDAMED185mm*80mm EUDAMEDSteam eye mask、Warm neck patch、Warm waist patch、Knee patch、Warm foot patch、Moxibustion paste、Hot compress 、Heating pad EUDAMEDSteam eye mask 185*80mm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973450210005 EUDAMED06973450213808 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697345021MHC01DG | Class I | Active |
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Manufacturer
- Manufacturer
- Changzhou Heart Girlfriends Biotechnology Co., Ltd.
- 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