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Zapato Terapeutico Franki T.38 +1 more model
EUDAMEDClass I (EU MDR)
Ref OF1550#38
Identity
- Trade Name
- ZAPATO TERAPEUTICO FRANKI T.38 ; THERAPEUTIC SHOE FRANKI EUDAMED
- Device Name
- Zapatos (Terapéuticos) EUDAMED
- Model / Reference
- OF1550#38 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435491804493 EUDAMED
- Basic UDI-DI
- 84350259ORL20415PZ EUDAMED
- EMDN Code
- Y063303 READY-MADE ORTHOTIC SHOES EUDAMED
- Models / Variants
- Zapato Terapeutico Franki T.38 EUDAMEDTherapeutic Shoe Franki 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
Yes
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
Zapato Terapeutico Franki T.38 +1 more model by Orliman, S.L.U. — Class I — MDR — listed in EUDAMED — 2 models — 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 | 84350259ORL20415PZ | Class I | Active |
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Manufacturer
- Manufacturer
- Orliman, S.L.U.
- EUDAMED SRN
- ES-MF-000001598
Sources (1)
- EUDAMED 6d4cfba3-463b-4200-a435-ee63992aa2e6 61 fields · synced Oct 6, 2026