Identity
- Trade Name
- Wrist Roll Exerciser EUDAMED
- Device Name
- Wrist Roll Exerciser EUDAMED
- Model / Reference
- - EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04571292661164 EUDAMED
- Basic UDI-DI
- 457129266116438 EUDAMED
- EMDN Code
- Z12069099 VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I 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
Wrist Roll Exerciser 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 | 457129266116438 | 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 1954844b-f233-4afd-a0c9-ef85228ae100 61 fields · synced Jun 14, 2026