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Muñequera Elástica Graduable +1 more model
EUDAMEDClass I (EU MDR)
Ref ACE501#12/U
Identity
- Trade Name
- MUÑEQUERA ELÁSTICA GRADUABLE ; ADJUSTABLE ELASTIC WRIST SUPPORT EUDAMED
- Device Name
- Órtesis de mano / muñeca - Elástica EUDAMED
- Model / Reference
- ACE501#12/U EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435025981300 EUDAMED
- Basic UDI-DI
- 84350259ORL20301PH EUDAMED
- EMDN Code
- Y060609 WRIST (FOREARM) ORTHOSES EUDAMED
- Models / Variants
- Muñequera Elástica Graduable EUDAMEDAdjustable Elastic Wrist Support 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
Muñequera Elástica Graduable +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 | 84350259ORL20301PH | Class I | Active |
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Manufacturer
- Manufacturer
- Orliman, S.L.U.
- EUDAMED SRN
- ES-MF-000001598
Sources (1)
- EUDAMED f2d23be4-47b0-4b59-87b0-63e582ec06aa 61 fields · synced Jun 19, 2026