Identity
- Trade Name
- Πέλμα Σιλικόνης 3/4 XLarge Orange Line EUDAMED
- Device Name
- Πέλμα Σιλικόνης 3/4 Orange Line EUDAMED
- Model / Reference
- 08321 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05205414202155 EUDAMED
- Basic UDI-DI
- 5205414083214N EUDAMED
- Direct Marketing DI
- 05205414202155 EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece 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
Πέλμα Σιλικόνης 3/4 XLarge Orange Line by Adco Orthopaedics Ltd — Class I — MDR — listed in EUDAMED — 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 | 5205414083214N | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Adco Orthopaedics Ltd
- EUDAMED SRN
- GR-MF-000013663
Sources (1)
- EUDAMED c8b8cb9d-7648-45be-b404-2d96d2d84c62 61 fields · synced Jul 12, 2026