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K2 Kinetic Foot with Pyramid
EUDAMEDClass I (EU MDR)
Ref SKF300-23-L-1S3
by Trulife Inc.
Identity
- Device Name
- K2 Kinetic Foot with Pyramid EUDAMED
- Model / Reference
- SKF300-23-L-1S3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00645517849805 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
K2 Kinetic 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 | 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 954e7f7b-1c3c-4568-af5c-92b917936499 61 fields · synced Oct 6, 2026