Identity
- Trade Name
- Paraffin Bath PARAPACK EUDAMED
- Device Name
- Paraffin Bath PARAPACK EUDAMED
- Model / Reference
- － EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04571292660952 EUDAMED
- Basic UDI-DI
- B-04571292660952 EUDAMED
- EMDN Code
- Z120619 PARAFFIN THERAPY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Paraffin Bath PARAPACK by OG Wellness Technologies Co., Ltd. Headquarters — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04571292660952 | Class IIa | 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 1b7d1e4d-fb35-4898-b83e-cebb3e925c98 61 fields · synced Jul 11, 2026