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1C64 Triton HD - L - without footshell
EUDAMEDClass I (EU MDR)
Ref 1C64=L26-3-P/0Model 1C64
Identity
- Trade Name
- 1C64 Triton HD - L - without footshell EUDAMED
- Device Name
- Triton Heavy Duty EUDAMED
- Model / Reference
- 1C64 EUDAMED1C64=L26-3-P/0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04064409044399 EUDAMED
- Basic UDI-DI
- 406440900000000001C64RY 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
1C64 Triton HD - L - without footshell by Otto Bock HealthCare LP — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Mechanical-resistance external ankle-foot prosthesis.
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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 | 406440900000000001C64RY | Class I | Active |
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Manufacturer
- Manufacturer
- Otto Bock HealthCare LP
- EUDAMED SRN
- US-MF-000019567
- Authorised Representative
- Ottobock SE & Co. KGaA DE-AR-000016531
Sources (1)
- EUDAMED 0690e758-475f-48a8-ae63-2f8f11e7c00e 61 fields · synced Sep 17, 2026