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RODILLA MONOCENT. FRENO CARGA - RODILLA MONOCENT. FRENO CARGA (Ti)
EUDAMEDClass I (EU MDR)
Ref 6H02T#UNI
Identity
- Trade Name
- RODILLA MONOCENT. FRENO CARGA (Ti) ; SINGLE AXIS FRICTION KNEE (TI) EUDAMED
- Device Name
- Rodillas EUDAMED
- Model / Reference
- 6H02T#UNI EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435025988064 EUDAMED
- Basic UDI-DI
- 84350259ORL20507Q7 EUDAMED
- EMDN Code
- Y062415 TRANSFEMORAL PROSTHESES (FOR AMPUTATION ABOVE KNEE) EUDAMED
- Models / Variants
- RODILLA MONOCENT. FRENO CARGA (Ti) EUDAMEDSINGLE AXIS FRICTION KNEE (TI) 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: Mechatronic external knee prosthesis
RODILLA MONOCENT. FRENO CARGA - RODILLA MONOCENT. FRENO CARGA (Ti) by Orliman, S.L.U. — Class I — MDR — listed in EUDAMED — 2 models
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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 | 84350259ORL20507Q7 | Class I | Active |
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Manufacturer
- Manufacturer
- Orliman, S.L.U.
- EUDAMED SRN
- ES-MF-000001598
Sources (1)
- EUDAMED 92bc1948-806a-4941-8922-c932e6c95343 61 fields · synced Oct 6, 2026