Identity
- Device Name
- ORTESIS ORTHO WEDGE EUDAMED
- Model / Reference
- 12.719.22 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08436026682579 EUDAMED
- Basic UDI-DI
- 84360266ORTHOWEDGES5 EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Ortesis Ortho Wedge by Laboratorios Herbitas, S.l. — 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 | 84360266ORTHOWEDGES5 | Class I | Active |
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Manufacturer
- Manufacturer
- Laboratorios Herbitas, S.l.
- EUDAMED SRN
- ES-MF-000004599
Sources (1)
- EUDAMED 3605864b-5f1e-4f19-a9a0-d4c86d734513 61 fields · synced Jun 18, 2026