Identity
- Trade Name
- Thrive Orthopedics FDA UDI
- Generic Name
- Ankle/foot orthosis FDA UDI
- Device Name
- Carbon Fiber Foot Plate EUDAMEDCarbon FLX Insole: US M16 - M16.5 FDA UDI
- Model / Reference
- FLXM16 EUDAMEDFDA UDI
- Description
- Carbon FLX Insole: US M16 - M16.5 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810079190874 EUDAMEDFDA UDI
- Basic UDI-DI
- 0081007919XGCFIS8 EUDAMED
- FDA Product Code
- IQI FDA UDI
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED
- GMDN Term
- Ankle/foot orthosis FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3475 FDA UDI
- Market of Registration
- Sweden 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
Yes
FDA UDI
Category: Ankle/foot orthosis
Carbon Fiber Foot Plate by Thrive Orthopedics — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 0081007919XGCFIS8 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Thrive Orthopedics
- EUDAMED SRN
- US-MF-000026394
- Authorised Representative
- Code of Practice AB SE-AR-000003002
Sources (2)
- EUDAMED c39c63ae-d99b-4239-96b4-db9de9364d25 61 fields · synced Jun 18, 2026
- FDA UDI e3ebd1e3-c59a-43c0-976f-2b34034c8688 33 fields · synced May 30, 2026