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Adapter, 1/4" Square to Hudson (Shukla Spine S9SPINE, Shukla Copter S9COPTER Sc…
EUDAMEDClass I (EU MDR)
Ref SAD005
Identity
- Trade Name
- Adapter, 1/4" Square to Hudson (Shukla Spine S9SPINE, Shukla Copter S9COPTER Screw Removal Systems) EUDAMED
- Device Name
- Adapter, 1/4" Square to Hudson (Shukla Spine S9SPINE, Shukla Copter S9COPTER Screw Removal Systems) EUDAMED
- Model / Reference
- SAD005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B756SAD0050 EUDAMED
- Basic UDI-DI
- ++B756SAD005S4 EUDAMED
- Direct Marketing DI
- +B756SAD0050 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
Adapter, 1/4" Square to Hudson (Shukla Spine S9SPINE, Shukla Copter S9COPTER Sc… 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 | ++B756SAD005S4 | 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 eedb36a1-5011-4c23-8a31-3169b3a17d00 61 fields · synced Oct 7, 2026