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Handle Assy, Osteotome, Twist Lock (S9KNEE Shukla Knee / Universal Knee Implant…
EUDAMEDClass I (EU MDR)
Ref SIN001
Identity
- Trade Name
- Handle Assy, Osteotome, Twist Lock (S9KNEE Shukla Knee / Universal Knee Implant Extraction System) EUDAMED
- Device Name
- Handle Assy, Osteotome, Twist Lock (S9KNEE Shukla Knee / Universal Knee Implant Extraction System) EUDAMED
- Model / Reference
- SIN001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B756SIN0010 EUDAMED
- Basic UDI-DI
- ++B756S9KNEEHANBK EUDAMED
- Direct Marketing DI
- +B756SIN0010 EUDAMED
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Handle Assy, Osteotome, Twist Lock (S9KNEE Shukla Knee / Universal Knee Implant… by S. S. White Technologies Inc/DBA Shukla Medical — Class I — MDR — listed…
Manufacturer's product page: Knee
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 | ++B756S9KNEEHANBK | Class I | Active |
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Manufacturer
- Manufacturer
- S. S. White Technologies Inc/DBA Shukla Medical
- EUDAMED SRN
- US-MF-000007058
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 7ee08a17-537c-490d-b774-54b68296fe41 61 fields · synced Oct 6, 2026