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OrthoSOLID-CARPI Wrist Orthosis-LONG RIGHT
EUDAMEDClass I (EU MDR)
Ref OS-301-DAModel 11-0040-SRRef OS-302-BA
by Orthobroker
Identity
- Trade Name
- OrthoSOLID-CARPI Wrist Orthosis-LONG RIGHT EUDAMED
- Device Name
- Embrace Wrist - Small Right EUDAMED
- Model / Reference
- 11-0040-SR EUDAMEDOS-301-DA EUDAMEDOS-302-BA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05404020409990 EUDAMED05404020409334 EUDAMED
- Basic UDI-DI
- 5404020402wristhandZ6 EUDAMED
- EMDN Code
- Y060612 WRIST-HAND ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
OrthoSOLID-CARPI Wrist Orthosis-LONG RIGHT by Orthobroker — 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 | 5404020402wristhandZ6 | Class I | Active |
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Manufacturer
- Manufacturer
- Orthobroker
- EUDAMED SRN
- BE-MF-000000331
Sources (2)
- EUDAMED a2d59849-2e80-4ec3-aa90-81ffd45bdc2f 61 fields · synced Jul 24, 2026
- EUDAMED 6c3ae9b5-b027-4d98-b12b-60fcc25a4525 61 fields · synced May 17, 2026