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Case, Spine System, Instruments (S9SPINE-CTL - Shukla Spine/ Universal Spinal S…
EUDAMEDClass I (EU MDR)
Ref SCS036
Identity
- Trade Name
- Case, Spine System, Instruments (S9SPINE-CTL - Shukla Spine/ Universal Spinal Screw Removal System) EUDAMED
- Device Name
- Case, Spine System, Instruments (S9SPINE-CTL - Shukla Spine/ Universal Spinal Screw Removal System) EUDAMED
- Model / Reference
- SCS036 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B756SCS0360 EUDAMED
- Basic UDI-DI
- ++B756S9SPINECTLCASEGX EUDAMED
- Direct Marketing DI
- +B756SCS0360 EUDAMED
- EMDN Code
- S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern 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
Case, Spine System, Instruments (S9SPINE-CTL - Shukla Spine/ Universal Spinal S… by S. S. White Technologies Inc/DBA Shukla Medical — Class I — MDR — listed…
Manufacturer's product page: Spine
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 | ++B756S9SPINECTLCASEGX | 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 bafb67bc-2499-4ffa-a883-7aeea543bde3 61 fields · synced Jun 19, 2026