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International KIT - Transtibial prosthetic device
EUDAMEDClass I (EU MDR)
Ref TT200XRiModel TT200
Identity
- Device Name
- International KIT - Transtibial prosthetic device EUDAMED
- Model / Reference
- TT200 EUDAMEDTT200XRi EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850049686228 EUDAMED
- Basic UDI-DI
- 0850049686TT200i64 EUDAMED
- Direct Marketing DI
- 00850049686228 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
Category: Mechanical-resistance external ankle-foot prosthesis
International KIT - Transtibial prosthetic device by iFIT Prosthetics — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Mechanical-resistance external ankle-foot prosthesis.
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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 b9be87c4-7335-49ed-b9d5-8cfd342ed632 61 fields · synced Jul 11, 2026