Identity
- Trade Name
- Hot Pack Heating Unit HYDRO PACMEL EUDAMED
- Device Name
- Hot Pack Heating Unit HYDRO PACMEL EUDAMED
- Model / Reference
- PX-350 EUDAMED－ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04571292660884 EUDAMED
- Basic UDI-DI
- 45712926608844A 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
Hot Pack Heating Unit HYDRO PACMEL 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 | 45712926608844A | 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 6f2acd1a-4be1-4f4c-9209-53be64ce770a 61 fields · synced Jul 14, 2026