Identity
- Trade Name
- Formthotics EUDAMEDFDA UDI
- Generic Name
- Orthotic insole, prefabricated, antimicrobial FDA UDI
- Device Name
- Formthotics Foot Orthotic Insole EUDAMEDFormthotics Med L/Volume Single Medium (Perf) - XXS FDA UDI
- Model / Reference
- FM01-LvSmBpGr-2S EUDAMEDFDA UDI
- Description
- Formthotics Med L/Volume Single Medium (Perf) - XXS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09419430002286 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
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
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 EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
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 915250f9-6e7b-4dd3-844f-8d04ffa9945f 61 fields · synced May 30, 2026
- FDA UDI 092717aa-f623-4fc7-a50f-1a25d72399a9 33 fields · synced May 30, 2026