Identity
- Trade Name
- Early Activity System EUDAMEDLeckey Ealy Activity System FDA UDI
- Generic Name
- Gymnasium mat FDA UDI
- Device Name
- Early Positioning EUDAMEDThe Leckey Early Activity System is a Colorful, comfortable, supportive activity system for children aged 0-36 months. FDA UDI
- Model / Reference
- 130 EUDAMEDEarly Activity System FDA UDI
- Description
- The Leckey Early Activity System is a Colorful, comfortable, supportive activity system for children aged 0-36 months. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05059804130005 EUDAMEDFDA UDI
- Basic UDI-DI
- 05059804107EarlyPos8M EUDAMED
- Direct Marketing DI
- 05059804130005 EUDAMED
- FDA Product Code
- ILS FDA UDI
- EMDN Code
- Y180999 CHAIRS / POSTURE SYSTEMS / SEAT POSITIONING AIDS - OTHER EUDAMED
- GMDN Term
- Gymnasium mat FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.5050 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Early Activity System by James Leckey Design Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 05059804107EarlyPos8M | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- James Leckey Design Ltd
- EUDAMED SRN
- XI-MF-000003572
Sources (2)
- EUDAMED 7bc412ba-5ebc-473e-951c-664f7a6a6d56 61 fields · synced Jul 9, 2026
- FDA UDI db838f7c-8252-4a22-a399-136d91254b0a 33 fields · synced May 30, 2026