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Strike Plate, Assy, Extended (S9BLADE - Shukla Blade - Universal Flexible Osteo…
EUDAMEDClass I (EU MDR)
Ref SMS023
Identity
- Trade Name
- Strike Plate, Assy, Extended (S9BLADE - Shukla Blade - Universal Flexible Osteotome Solution) EUDAMED
- Device Name
- Strike Plate, Assy, Extended (S9BLADE - Shukla Blade - Universal Flexible Osteotome Solution) EUDAMED
- Model / Reference
- SMS023 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B756SMS0230 EUDAMED
- Basic UDI-DI
- ++B756S9BLADESTRK5 EUDAMED
- Direct Marketing DI
- +B756SMS0230 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
Strike Plate, Assy, Extended (S9BLADE - Shukla Blade - Universal Flexible Osteo… by S. S. White Technologies Inc/DBA Shukla Medical — Class I — MDR — listed…
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 | ++B756S9BLADESTRK5 | 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 7a37c956-0790-4c0c-8968-6bc93ac37a4c 61 fields · synced Oct 7, 2026