Identity
- Device Name
- 11.058.15 EUDAMED
- Model / Reference
- 11.058.16 EUDAMED11.058.15 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435135520949 EUDAMED08435135520932 EUDAMED
- Basic UDI-DI
- 84351355COMODIDUPLOXU 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
11.058.15 by Laboratorios Herbitas, S.l. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 84351355COMODIDUPLOXU | Class I | Active |
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Manufacturer
- Manufacturer
- Laboratorios Herbitas, S.l.
- EUDAMED SRN
- ES-MF-000004599
Sources (2)
- EUDAMED a61699a6-5424-4745-a463-e89efc8ef150 61 fields · synced Jul 14, 2026
- EUDAMED 485c8413-9882-4bc0-ade8-9362dfd7add3 61 fields · synced May 19, 2026