Spex Limited
FDA UDIEUDAMEDClass I (US FDA UDI)
by Spex Limited
Identity
- Trade Name
- Spex EUDAMEDSpex Limited FDA UDI
- Generic Name
- Wheelchair head/trunk support, prefabricated FDA UDI
- Device Name
- Lateral Trunk support EUDAMEDBroad lateral pad with standard cover including Gel-foam overlay, size 6; 230mm high x 175mm deep FDA UDI
- Model / Reference
- 1266-3036-600 EUDAMEDFDA UDI
- Description
- Broad lateral pad with standard cover including Gel-foam overlay, size 6; 230mm high x 175mm deep FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09420082909564 EUDAMEDFDA UDI
- Basic UDI-DI
- 94200517LATERALTRUNKRU EUDAMED
- Direct Marketing DI
- 09420082909564 EUDAMED
- FDA Product Code
- IMS FDA UDI
- EMDN Code
- Y122499 WHEELCHAIRS ACCESSORIES - OTHER EUDAMED
- GMDN Term
- Wheelchair head/trunk support, prefabricated FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3910 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Wheelchair head/trunk support, prefabricated
Spex Limited by Spex Limited — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Spex Limited
Sources (2)
- FDA UDI 6bc8413a-7d73-4bb2-839e-dfa848b0a30d 34 fields · synced Jul 13, 2026
- EUDAMED 90a9e051-baf5-4252-830e-8cac6d1a7eb1 61 fields · synced Jul 13, 2026