Identity
- Trade Name
- Thrive Orthopedics FDA UDI
- Generic Name
- Ankle/foot orthosis FDA UDI
- Device Name
- Mach8™ - Ankle Brace EUDAMEDMach8™ - Ankle Brace - M FDA UDI
- Model / Reference
- MACH-M EUDAMEDFDA UDI
- Description
- Mach8™ - Ankle Brace - M FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810079190959 EUDAMEDFDA UDI
- Basic UDI-DI
- 081007919MACH8Z5 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
Mach8™ - Ankle Brace by Thrive Orthopedics — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Ankle/foot orthosis.
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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 | 081007919MACH8Z5 | 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 2f025f4c-d8d7-4039-9b46-b3d1d8729204 61 fields · synced Jul 21, 2026
- FDA UDI 4f05c585-aaae-4b87-99fd-74d30d462d4c 33 fields · synced May 30, 2026