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Ort. Codo Izqd. Ctl Flexo Extension Elbowlution T.uni +1 more model
EUDAMEDClass I (EU MDR)
Ref 94305I#UNI
Identity
- Trade Name
- ORT. CODO IZQD. CTL FLEXO EXTENSION ELBOWLUTION T.UNI ; TELESCOPING ROM ELBOW BRACE LEFT EUDAMED
- Device Name
- Ortesis de miembro superior EUDAMED
- Model / Reference
- 94305I#UNI EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435491806121 EUDAMED
- Basic UDI-DI
- 84350259ORL20309PZ EUDAMED
- EMDN Code
- Y060615 ELBOW ORTHOSES EUDAMED
- Models / Variants
- Telescoping Rom Elbow Brace 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
Ort. Codo Izqd. Ctl Flexo Extension Elbowlution T.uni +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 | 84350259ORL20309PZ | Class I | Active |
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Manufacturer
- Manufacturer
- Orliman, S.L.U.
- EUDAMED SRN
- ES-MF-000001598
Sources (1)
- EUDAMED 140635c7-8f64-40d2-9f66-a4a8238ad207 61 fields · synced Jun 18, 2026