Identity
- Trade Name
- ACCESORIO PULGAR ACE511 ; THUMB ACCESSORY ACE511 EUDAMED
- Device Name
- Férulas dedo EUDAMED
- Model / Reference
- ACE512P#2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435491819671 EUDAMED
- Basic UDI-DI
- 84350259ORL20306PT EUDAMED
- EMDN Code
- Y060603 FINGERS ORTHOSES EUDAMED
- Models / Variants
- Accesorio Pulgar Ace511 EUDAMEDThumb Accessory Ace511 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
Accesorio Pulgar Ace511 +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 | 84350259ORL20306PT | Class I | Active |
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Manufacturer
- Manufacturer
- Orliman, S.L.U.
- EUDAMED SRN
- ES-MF-000001598
Sources (1)
- EUDAMED 54e6a444-c0af-44e6-bacc-a693f2980a13 61 fields · synced Jun 18, 2026