Identity
- Trade Name
- Traction Unit ORTHOTRAC EUDAMED
- Device Name
- Traction Unit ORTHOTRAC EUDAMED
- Model / Reference
- OL-1200 EUDAMED－ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04571292660662 EUDAMED
- Basic UDI-DI
- B-04571292660662 EUDAMED
- EMDN Code
- Z12130202 TRACTION 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
Traction Unit ORTHOTRAC 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-04571292660662 | 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 c4114cd4-27f9-4ddb-afcb-de749ed088f5 61 fields · synced Jul 31, 2026