Identity
- Trade Name
- Arion Proth-Pro Small EUDAMEDArion Proth-Pro FDA UDI
- Generic Name
- Stump sock FDA UDI
- Device Name
- Arion Proth-Pro EUDAMEDDonning aid for transfemoral prostheses FDA UDI
- Model / Reference
- E02701 EUDAMEDExtra Small FDA UDI
- Description
- Donning aid for transfemoral prostheses FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08717127931552 EUDAMEDFDA UDI
- Basic UDI-DI
- 871712793PROTH-PRO78 EUDAMED
- Direct Marketing DI
- 08717127931552 EUDAMED
- FDA Product Code
- IPM FDA UDI
- EMDN Code
- Y062415 TRANSFEMORAL PROSTHESES (FOR AMPUTATION ABOVE KNEE) EUDAMED
- GMDN Term
- Stump sock FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3025 FDA UDI
- Market of Registration
- Netherlands 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
No
FDA UDI
MR Safe FDA UDI
Category: Mechatronic external knee prosthesis
Arion Proth-Pro Small by Arion Slide Solutions B.V. — 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 | 871712793PROTH-PRO78 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Arion Slide Solutions B.V.
- EUDAMED SRN
- NL-MF-000002671
Sources (2)
- EUDAMED 039814dd-5080-4457-be6f-e8ad06bcfcd6 61 fields · synced Jun 19, 2026
- FDA UDI d589ffd7-a526-40c3-9ce6-73ae32f84172 33 fields · synced May 30, 2026