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Calcetín Pie Diabético Relax T.3 M: 41-43, 5 +1 more model
EUDAMEDClass I (EU MDR)
Ref OV03B005#3
Identity
- Trade Name
- CALCETÍN PIE DIABÉTICO RELAX T.3 M: 41-43,5 ; RELAXDIABETICSOCK AB1 CCL0 WHITE+GR EUDAMED
- Device Name
- Zapatos (Calcetines) EUDAMED
- Model / Reference
- OV03B005#3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435025984806 EUDAMED
- Basic UDI-DI
- 84350259ORL20416Q3 EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
- Models / Variants
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
Calcetín Pie Diabético Relax T.3 M: 41-43, 5 +1 more model by Orliman, S.L.U. — Class I — MDR — listed in EUDAMED — 2 models — 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 | 84350259ORL20416Q3 | Class I | Active |
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Manufacturer
- Manufacturer
- Orliman, S.L.U.
- EUDAMED SRN
- ES-MF-000001598
Sources (1)
- EUDAMED a19b766b-eadb-46b3-925b-0f45c8664886 61 fields · synced Oct 6, 2026