Identity
- Trade Name
- Taleo Side Flex EUDAMED
- Device Name
- Taleo Side Flex EUDAMED
- Model / Reference
- 1C58 EUDAMED1C58=R30-6-P/0-OB EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04064409063840 EUDAMED
- Basic UDI-DI
- 406440900000000001C58S5 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
Taleo Side Flex 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 | 406440900000000001C58S5 | 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 77e24538-4afd-4ddd-ac15-6985e4972831 61 fields · synced Sep 17, 2026