← Back to catalogue
K2 Kinetic Foot with Pyramid
EUDAMEDClass I (EU MDR)
Ref UKF103-28-R-2A8
by Trulife Inc.
Identity
- Device Name
- K2 Kinetic Foot with Pyramid EUDAMED
- Model / Reference
- UKF103-28-R-2A8 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00645517847405 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
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 | 00645517FootK2YR | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Trulife Inc.
- EUDAMED SRN
- US-MF-000009657
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 59165e9a-fd4c-4626-a84c-f6439eea9fa5 61 fields · synced Jul 8, 2026