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K3 Foot with Pyramid
EUDAMEDClass I (EU MDR)
Ref UEF190-27-L-3M7
by Trulife Inc.
Identity
- Device Name
- K3 Foot with Pyramid EUDAMED
- Model / Reference
- UEF190-27-L-3M7 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00645517830889 EUDAMED
- Basic UDI-DI
- 00645517FootK3YT EUDAMED
- EMDN Code
- Y062409 TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
K3 Foot with Pyramid by Trulife Inc. — 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 | 00645517FootK3YT | Class I | Active |
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Manufacturer
- Manufacturer
- Trulife Inc.
- EUDAMED SRN
- US-MF-000009657
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 20527fa3-42b0-42d8-a744-67ebb913fc94 61 fields · synced Jul 8, 2026