← Back to catalogue
iFIT Prosthesis
EUDAMEDClass I (EU MDR)
Ref TT200TRiModel TT200Ref TF300LiModel iFITTF300Ref TT200RiRef TT200WLiRef TF300WRiRef TT200XLiRef TT200TLiRef TT200WRi
Identity
- Trade Name
- iFIT Prosthesis EUDAMED
- Device Name
- International KIT - Transtibial prosthetic device EUDAMEDiFIT Transfemoral Prosthesis EUDAMED
- Model / Reference
- TT200 EUDAMEDTT200TRi EUDAMEDiFITTF300 EUDAMEDTF300Li EUDAMEDTT200Ri EUDAMEDTT200WLi EUDAMEDTF300WRi EUDAMEDTT200XLi EUDAMEDTT200TLi EUDAMEDTT200WRi EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850049686204 EUDAMED00850049686235 EUDAMED00850049686167 EUDAMED00850049686174 EUDAMED00850049686266 EUDAMED00850049686211 EUDAMED00850049686198 EUDAMED00850049686181 EUDAMED
- Basic UDI-DI
- 0850049686TT200i64 EUDAMED0850049686TF300iZE EUDAMED
- Direct Marketing DI
- 00850049686204 EUDAMED00850049686235 EUDAMED00850049686167 EUDAMED00850049686174 EUDAMED00850049686266 EUDAMED00850049686211 EUDAMED00850049686198 EUDAMED00850049686181 EUDAMED
- EMDN Code
- Y062409 TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE) EUDAMEDY062415 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: Mechanical-resistance external ankle-foot prosthesis
iFIT Prosthesis by iFIT Prosthetics — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Mechanical-resistance external ankle-foot prosthesis.
- TruStep — COLLEGE PARK INDUSTRIES, INC. · Class I
- Iceross Comfort® Locking — Össur Iceland ehf. · Class I
- Tribute — COLLEGE PARK INDUSTRIES, INC. · Class I
- Venture — COLLEGE PARK INDUSTRIES, INC. · Class I
- Aviator — COLLEGE PARK INDUSTRIES, INC. · Class I
- Soleus — COLLEGE PARK INDUSTRIES, INC. · Class I
- Proprio Foot® — Össur Iceland ehf. · Class I
- Onyx — COLLEGE PARK INDUSTRIES, INC. · 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 | 0850049686TT200i64 | 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 (8)
- EUDAMED e4f47f2b-b712-4111-9de2-eec64ebf486d 61 fields · synced Aug 3, 2026
- EUDAMED 564b2c8a-4f18-4428-91b7-cad33284f075 61 fields · synced May 17, 2026
- EUDAMED e4d6a7bf-1b39-4bf2-838b-2d6f082059c9 61 fields · synced May 17, 2026
- EUDAMED d48ab35b-d1b4-4ee5-944f-f75cdb7f7c3a 61 fields · synced May 17, 2026
- EUDAMED 61f04ab9-a8bd-4b6c-8b09-153e603eae53 61 fields · synced May 18, 2026
- EUDAMED c4607ca2-1fa9-4f29-9f9a-d4a69d021e4a 61 fields · synced May 18, 2026
- EUDAMED 7a346c52-49d2-41b0-8af3-718168823663 61 fields · synced May 18, 2026
- EUDAMED 1de65960-775d-4c50-8205-ce8d819683dc 61 fields · synced May 19, 2026