Identity
- Trade Name
- iFIT Prosthesis EUDAMED
- Device Name
- iFIT Transfemoral Prosthesis EUDAMED
- Model / Reference
- iFITTF300 EUDAMEDTF300Ri EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850049686242 EUDAMED
- Basic UDI-DI
- 0850049686TF300iZE EUDAMED
- Direct Marketing DI
- 00850049686242 EUDAMED
- EMDN Code
- Y062415 TRANSFEMORAL PROSTHESES (FOR AMPUTATION ABOVE KNEE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Mechatronic external knee prosthesis
iFIT Prosthesis by iFIT Prosthetics — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Mechatronic external knee prosthesis.
- VGK-S — Orthomobility Ltd. · Class I
- NORD LINER TF CYLINDRICAL - TYPE 3.1 NF-53 — Nord Ability AB · Class I
- 5 Bar Knee Joint for AK with manual locking, Al — ST&G Corporation · Class I
- Symphony Cushion Liner for AK 32 — ST&G Corporation · Class I
- Socket adapter with adjustment core support (aluminium) — Elitex Prodexim SRL · Class I
- AKOS — Össur Iceland ehf. · Class I
- MERCURY EXT. KNEE PROSTHESIS 30mm SWING — BLATCHFORD PRODUCTS LIMITED · Class I
- Avior Accessories Kit (Rest of World) — BLATCHFORD PRODUCTS LIMITED · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0850049686TF300iZE | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- iFIT Prosthetics
- EUDAMED SRN
- US-MF-000032928
- Authorised Representative
- Eurolink Europe Compliance Limited IE-AR-000002852
Sources (1)
- EUDAMED d98f7bed-7aaf-4e53-a129-5b6fe7aefc37 61 fields · synced Jun 18, 2026