Identity
- Trade Name
- iFIT Prosthesis EUDAMED
- Device Name
- International KIT - Transtibial prosthetic device EUDAMED
- Model / Reference
- TT200 EUDAMEDTT200Ni EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850049686143 EUDAMED
- Basic UDI-DI
- 0850049686TT200i64 EUDAMED
- Direct Marketing DI
- 00850049686143 EUDAMED
- EMDN Code
- Y062409 TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER 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
iFIT Prosthesis by iFIT Prosthetics — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 |
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Manufacturer
- Manufacturer
- iFIT Prosthetics
- EUDAMED SRN
- US-MF-000032928
- Authorised Representative
- Eurolink Europe Compliance Limited IE-AR-000002852
Sources (1)
- EUDAMED 139bfed3-efd7-4399-93d1-cff4f0672d1f 61 fields · synced Jun 19, 2026