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Mitchell Ponseti® Ankle Foot Orthosis
EUDAMEDFDA UDIClass I (EU MDR)
Ref AFO-P6-0-PRW
Identity
- Trade Name
- Mitchell Ponseti® Ankle Foot Orthosis EUDAMEDMD Orthopaedics FDA UDI
- Generic Name
- Ankle/foot orthosis FDA UDI
- Device Name
- Mitchell Ponseti® Ankle Foot Orthosis (AFO) EUDAMEDAFO SIZE P6-0 PAIR GRAY FDA UDI
- Model / Reference
- AFO-P6-0-PRW EUDAMEDFDA UDI
- Description
- AFO SIZE P6-0 PAIR GRAY FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810060887141 EUDAMEDFDA UDI
- Basic UDI-DI
- 08100608831000036SY EUDAMED
- Direct Marketing DI
- 00810060887141 EUDAMED
- FDA Product Code
- KNP 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
- Northern Ireland 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
Yes
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
Mitchell Ponseti® Ankle Foot Orthosis by MD Orthopaedics — 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 | 08100608831000036SY | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- MD Orthopaedics
- EUDAMED SRN
- US-MF-000007513
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED c4819fbf-a3ff-4bc2-b074-7c9712c5b6d7 61 fields · synced Jun 19, 2026
- FDA UDI a8243e7b-90af-4733-b3cb-22f7d520186b 33 fields · synced May 30, 2026