Identity
- Trade Name
- Hip Orthosis EUDAMED
- Device Name
- Post-OP Brace (Hip orthosis) EUDAMED
- Model / Reference
- 261002(REGULAR/Left/White) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719964461975 EUDAMED
- Basic UDI-DI
- 47199644626WG EUDAMED
- EMDN Code
- Y061215 HIP ORTHOSES (INCLUDING ABDUCTION ORTHOSES) 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
Hip Orthosis by Orthotech Rehabilitation Co., Ltd. — 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 | 47199644626WG | Class I | Active |
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Manufacturer
- Manufacturer
- Orthotech Rehabilitation Co., Ltd.
- EUDAMED SRN
- CN-MF-000051924
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 406998d5-7837-4ac8-8844-2528d2e1e9ae 61 fields · synced Jun 18, 2026
- EUDAMED 9d0d9bd7-859f-4602-be8e-21eb6557060c 61 fields · synced Jun 18, 2026