Identity
- Trade Name
- Moist Heat Pack Fine Fit Pack EUDAMED
- Device Name
- Moist Heat Pack Fine Fit Pack EUDAMED
- Model / Reference
- HR-5SM EUDAMED－ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04571292660976 EUDAMED
- Basic UDI-DI
- 45712926609764G EUDAMED
- EMDN Code
- Z120602 PHYSIOTHERAPY EQUIPMENT EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Moist Heat Pack Fine Fit Pack by OG Wellness Technologies Co., Ltd. Headquarters — 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 | 45712926609764G | Class I | Active |
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Manufacturer
- Manufacturer
- OG Wellness Technologies Co., Ltd. Headquarters
- EUDAMED SRN
- JP-MF-000002613
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 836bf8d5-9ae5-432d-beb0-780bc4f2ab8e 61 fields · synced Jul 14, 2026