Identity
- Trade Name
- Squiggles Stander EUDAMEDSquiggles+ EUDAMEDLeckey Squiggles Stander FDA UDI
- Generic Name
- Manual stander/exerciser FDA UDI
- Device Name
- Standing EUDAMEDVersatile, supportive, compact stander which gives children a whole new view of the world. FDA UDI
- Model / Reference
- 118-600 EUDAMED184-600 EUDAMEDSquiggles Stander FDA UDI
- Description
- Versatile, supportive, compact stander which gives children a whole new view of the world. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05059804118003 EUDAMEDFDA UDI05059804184008 EUDAMED
- Basic UDI-DI
- 05059804102StandingEW EUDAMED
- Direct Marketing DI
- 05059804118003 EUDAMED05059804184008 EUDAMED
- FDA Product Code
- INM FDA UDI
- EMDN Code
- Y050202 STANDING FRAMES EUDAMED
- GMDN Term
- Manual stander/exerciser FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3100 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Squiggles Stander 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 | 05059804102StandingEW | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- James Leckey Design Ltd
- EUDAMED SRN
- XI-MF-000003572
Sources (3)
- EUDAMED e7df08e2-0515-41dc-ad59-641ffc8385e1 61 fields · synced Jul 29, 2026
- EUDAMED 2b4e3b73-ffd6-4d6c-8f12-6dd427efcfe0 61 fields · synced May 19, 2026
- FDA UDI e1d13f3a-fcba-47e6-90f5-f89e5db946c1 33 fields · synced May 30, 2026