Identity
- Trade Name
- Express EUDAMEDFormthotics FDA UDI
- Generic Name
- Orthotic insole, prefabricated, non-antimicrobial FDA UDI
- Device Name
- Express Ready-Fit Orthotic Insoles EUDAMEDExpress Kit Full Length Red - M FDA UDI
- Model / Reference
- EFl-01-Re-M EUDAMEDFDA UDI
- Description
- Express Kit Full Length Red - M FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09419430004945 EUDAMEDFDA UDI
- Basic UDI-DI
- 941943000002C4 EUDAMED
- FDA Product Code
- IQI FDA UDI
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
- GMDN Term
- Orthotic insole, prefabricated, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3475 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
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
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Orthotic insole, prefabricated, non-antimicrobial
Formthotics by Foot Science International 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
- Foot Science International Limited
Sources (2)
- FDA UDI f0f02176-216d-4bc3-9700-3c5ecf40a7d4 33 fields · synced Jul 29, 2026
- EUDAMED 521e9bee-24a0-4f55-b950-4c07ef29c124 61 fields · synced Jul 29, 2026