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K1 Foot with Pyramid K1-K2
EUDAMEDClass I (EU MDR)
Ref SCH113-28L
by Trulife Inc.
Identity
- Device Name
- K1 Foot with Pyramid K1-K2 EUDAMED
- Model / Reference
- SCH113-28L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00645517866345 EUDAMED
- Basic UDI-DI
- 00645517FootK1YP 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
K1 Foot with Pyramid K1-K2 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 | 00645517FootK1YP | 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 f3c899ca-b696-418d-a686-da32b1a36c16 61 fields · synced Jun 19, 2026