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K2 Kinetic Foot with Pyramid
EUDAMEDClass I (EU MDR)
Ref UKF103-25-L-4B5
by Trulife Inc.
Identity
- Device Name
- K2 Kinetic Foot with Pyramid EUDAMED
- Model / Reference
- UKF103-25-L-4B5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00645517847078 EUDAMED
- Basic UDI-DI
- 00645517FootK2YR 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
Category: Mechanical-resistance external ankle-foot prosthesis
K2 Kinetic Foot with Pyramid by Trulife Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 00645517FootK2YR | 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 49f307b3-b1e3-4b50-8826-7d091c9fac33 61 fields · synced Aug 1, 2026