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KJT, SafetyStride Ti 3/4x3/16in LL/RM
EUDAMEDClass I (EU MDR)
Ref 9005-A6TI-XModel 9005
Identity
- Trade Name
- KJT, SafetyStride Ti 3/4x3/16in LL/RM EUDAMED
- Device Name
- SafetyStride EUDAMED
- Model / Reference
- 9005 EUDAMED9005-A6TI-X EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00194545092443 EUDAMED
- Basic UDI-DI
- 19454590058N EUDAMED
- EMDN Code
- Y061209 KNEE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
KJT, SafetyStride Ti 3/4x3/16in LL/RM by Becker Orthopedic Appliance Company — 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 | 19454590058N | Class I | Active |
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Manufacturer
- Manufacturer
- Becker Orthopedic Appliance Company
- EUDAMED SRN
- US-MF-000004002
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED df94efa0-5830-4870-b44a-0ca63a9dbfa4 61 fields · synced Oct 8, 2026