Identity
- Trade Name
- Formthotics EUDAMEDFDA UDI
- Generic Name
- Orthotic insole, prefabricated, antimicrobial FDA UDI
- Device Name
- Formthotics Foot Orthotic Insole EUDAMEDFormthotics Medical SlimFit Dual Medium (Perf) - M FDA UDI
- Model / Reference
- FM01-SfDmBpGg-ME EUDAMEDFDA UDI
- Description
- Formthotics Medical SlimFit Dual Medium (Perf) - M FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09419430002477 EUDAMEDFDA UDI
- Basic UDI-DI
- 941943000001C2 EUDAMED
- FDA Product Code
- IQI FDA UDI
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
- GMDN Term
- Orthotic insole, prefabricated, 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
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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthotic insole, prefabricated, 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
European Union Unknown
MDR
United States Pending data
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 b574f528-53b7-4f37-a13d-fea88e832ff1 33 fields · synced Oct 5, 2026
- EUDAMED 84d185f5-edea-4297-8c15-5d046afa9530 61 fields · synced Oct 5, 2026