Identity
- Trade Name
- Playpack EUDAMED
- Device Name
- Early Positioning EUDAMED
- Model / Reference
- 165 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05059804165007 EUDAMED
- Basic UDI-DI
- 05059804107EarlyPos8M EUDAMED
- Direct Marketing DI
- 05059804165007 EUDAMED
- EMDN Code
- Y180999 CHAIRS / POSTURE SYSTEMS / SEAT POSITIONING AIDS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern 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
Playpack by James Leckey Design 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 | 05059804107EarlyPos8M | Class I | Active |
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Manufacturer
- Manufacturer
- James Leckey Design Ltd
- EUDAMED SRN
- XI-MF-000003572
Sources (1)
- EUDAMED 6d40eeb6-4beb-49a2-b8c0-f2bf9c862270 61 fields · synced Jul 16, 2026