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Ortesis Textil Funcional Izqd. Gonartec Advance T.2 M: 35-38 +1 more model
EUDAMEDClass I (EU MDR)
Ref OCR400I#2
Identity
- Trade Name
- ORTESIS TEXTIL FUNCIONAL IZQD. GONARTEC ADVANCE T.2 M: 35-38 ; FUNCTIONAL TEXTIL ORTHOSIS LEFT EUDAMED
- Device Name
- Rodilleras estabilizadoras/articuladas EUDAMED
- Model / Reference
- OCR400I#2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435491814751 EUDAMED
- Basic UDI-DI
- 84350259ORL20403PS EUDAMED
- EMDN Code
- Y061209 KNEE ORTHOSES EUDAMED
- Models / Variants
- Functional Textil Orthosis Left 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 Textil Funcional Izqd. Gonartec Advance T.2 M: 35-38 +1 more model by Orliman, S.L.U. — Class I — MDR — listed in EUDAMED — 2 models
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 | 84350259ORL20403PS | Class I | Active |
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Manufacturer
- Manufacturer
- Orliman, S.L.U.
- EUDAMED SRN
- ES-MF-000001598
Sources (1)
- EUDAMED c356ccc4-4a86-46e7-af9a-09cf50e9410f 61 fields · synced Jun 19, 2026