Identity
- Trade Name
- Ardoo EUDAMED
- Device Name
- Ardoo Caresafe Stand Aid Kit EUDAMED
- Model / Reference
- ASAK001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060225390183 EUDAMED
- Basic UDI-DI
- 506022539ARDOOS01KG EUDAMED
- EMDN Code
- Y050201 STANDING SUPPORT GAIT TRAINERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Ardoo by Polymorit 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 | 506022539ARDOOS01KG | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Polymorit Ltd
- EUDAMED SRN
- GB-MF-000024688
- Authorised Representative
- Eurolink Europe Compliance Limited IE-AR-000002852
Sources (1)
- EUDAMED 2b3815db-38d4-4974-b4bf-d9b91065f029 61 fields · synced Jun 19, 2026