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Hot Water Bag
EUDAMEDClass I (EU MDR)
Ref 2.2LModel 0.5L 1.0L 1.5L 1.75L 2.0L 2.2L 2.5L 3.9LRef 3.9LRef 1.5LRef 2.5LRef 1.0L
Identity
- Device Name
- Hot Water Bag EUDAMED
- Model / Reference
- 0.5L 1.0L 1.5L 1.75L 2.0L 2.2L 2.5L 3.9L EUDAMED2.2L EUDAMED3.9L EUDAMED1.5L EUDAMED2.5L EUDAMED1.0L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975918770052 EUDAMED06975918770076 EUDAMED06975918770021 EUDAMED06975918770069 EUDAMED06975918770014 EUDAMED
- Basic UDI-DI
- 697591877HWB01UB 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
Category: Hot/cold therapy pack, reusable
Hot Water Bag by Nanjing Ihome Comfort Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Hot/cold therapy pack, reusable.
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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 | 697591877HWB01UB | Class I | Active |
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Manufacturer
- Manufacturer
- Nanjing Ihome Comfort Co., Ltd
- EUDAMED SRN
- CN-MF-000037214
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (5)
- EUDAMED 26e648a1-15de-4222-bd3e-f1bbf3d282a4 61 fields · synced Jul 26, 2026
- EUDAMED 1ae7bade-b9c8-4b21-a9dc-46c21c2bc943 61 fields · synced May 17, 2026
- EUDAMED fde23e1f-f90d-483e-9dc2-d9a416a0c609 61 fields · synced May 17, 2026
- EUDAMED 8cab983f-8955-44ea-99f0-cb6d411c0848 61 fields · synced May 18, 2026
- EUDAMED 5ad25a00-bcce-40f1-bda5-8e3bbc869dde 61 fields · synced May 19, 2026