Identity
- Trade Name
- Formthotics EUDAMEDFDA UDI
- Generic Name
- Orthotic insole, prefabricated, antimicrobial FDA UDI
- Device Name
- Formthotics Foot Orthotic Insole EUDAMEDFormthotics Medical Original Single Hard - XXS FDA UDI
- Model / Reference
- FM01-OrShA-Re-2S EUDAMEDFDA UDI
- Description
- Formthotics Medical Original Single Hard - XXS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09419430003085 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
Formthotics by Foot Science International Limited — 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 | 941943000001C2 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Foot Science International Limited
- EUDAMED SRN
- NZ-MF-000044443
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 03cc707c-3e2a-4d44-a510-72457724fee4 61 fields · synced May 30, 2026
- FDA UDI a5bc5644-0811-419a-a548-2166bec0f969 33 fields · synced May 30, 2026