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Ortesis Heel Wedge
EUDAMEDClass I (EU MDR)
Ref 12.719.12Ref 12.719.14Ref 12.719.10
Identity
- Device Name
- ORTESIS HEEL WEDGE EUDAMED
- Model / Reference
- 12.719.12 EUDAMED12.719.14 EUDAMED12.719.10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435135535837 EUDAMED08435135535851 EUDAMED08435135535813 EUDAMED
- Basic UDI-DI
- 84351355HEELWEDGEDY 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
Category: Orthotic insole, prefabricated, non-antimicrobial
Ortesis Heel Wedge by Laboratorios Herbitas, S.l. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Orthotic insole, prefabricated, non-antimicrobial.
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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 | 84351355HEELWEDGEDY | Class I | Active |
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Manufacturer
- Manufacturer
- Laboratorios Herbitas, S.l.
- EUDAMED SRN
- ES-MF-000004599
Sources (3)
- EUDAMED 59a0af75-b10d-4cd5-9b49-1c30228bd41c 61 fields · synced Jul 28, 2026
- EUDAMED b578608a-ba28-45e6-b9e5-06c7d40180cc 61 fields · synced May 16, 2026
- EUDAMED 58c1606d-b5ea-4e95-ad54-427d3b875de4 61 fields · synced May 17, 2026