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Wrench, Assy Ratcheting 11/16" & Open End 5/16" (S9NAIL - Shukla NAIL/ Shukla U…
EUDAMEDClass I (EU MDR)
Ref SWR007
Identity
- Trade Name
- Wrench, Assy Ratcheting 11/16" & Open End 5/16" (S9NAIL - Shukla NAIL/ Shukla Universal IM Nail Extraction System) EUDAMED
- Device Name
- Wrench, Assy Ratcheting 11/16" & Open End 5/16" (S9NAIL - Shukla NAIL/ Shukla Universal IM Nail Extraction System) EUDAMED
- Model / Reference
- SWR007 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B756SWR0070 EUDAMED
- Basic UDI-DI
- ++B756S9NAILWR49 EUDAMED
- Direct Marketing DI
- +B756SWR0070 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
Wrench, Assy Ratcheting 11/16" & Open End 5/16" (S9NAIL - Shukla NAIL/ Shukla U… by S. S. White Technologies Inc/DBA Shukla Medical — Class I — MDR — listed…
Manufacturer's product page: Nail
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 | ++B756S9NAILWR49 | 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 7f6ead18-9fb4-4c96-bb3a-c90c60dcb11b 61 fields · synced Oct 6, 2026