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Extension Assy, 12" (Shukla Spine S9SPINE-CTL, Shukla Copter S9COPTER Screw Rem…
EUDAMEDClass I (EU MDR)
Ref SXN010
Identity
- Trade Name
- Extension Assy, 12" (Shukla Spine S9SPINE-CTL, Shukla Copter S9COPTER Screw Removal Systems) EUDAMED
- Device Name
- Extension Assy, 12" (Shukla Spine S9SPINE-CTL, Shukla Copter S9COPTER Screw Removal Systems) EUDAMED
- Model / Reference
- SXN010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B756SXN0100 EUDAMED
- Basic UDI-DI
- ++B756SXN01043 EUDAMED
- Direct Marketing DI
- +B756SXN0100 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
Extension Assy, 12" (Shukla Spine S9SPINE-CTL, Shukla Copter S9COPTER Screw Rem… by S. S. White Technologies Inc/DBA Shukla Medical — Class I — MDR — listed…
Manufacturer's product page: SHUKLA Copter
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 | ++B756SXN01043 | 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 28be7de0-874e-4136-a6ae-00167e8d6088 61 fields · synced Oct 7, 2026