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Hammer Assy, Slide (S9BLADE - Shukla Blade - Universal Flexible Osteotome Solut…
EUDAMEDClass I (EU MDR)
Ref SIN005
Identity
- Trade Name
- Hammer Assy, Slide (S9BLADE - Shukla Blade - Universal Flexible Osteotome Solution) EUDAMED
- Device Name
- Hammer Assy, Slide (S9BLADE - Shukla Blade - Universal Flexible Osteotome Solution) EUDAMED
- Model / Reference
- SIN005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B756SIN0050 EUDAMED
- Basic UDI-DI
- ++B756S9BLADEMALG2 EUDAMED
- Direct Marketing DI
- +B756SIN0050 EUDAMED
- EMDN Code
- L0903 ORTHOPAEDIC SURGERY HAMMERS, REUSABLE 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
Hammer Assy, Slide (S9BLADE - Shukla Blade - Universal Flexible Osteotome Solut… 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 | ++B756S9BLADEMALG2 | 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 f1f619aa-60dd-4955-98aa-e88c616f7c1d 61 fields · synced Oct 6, 2026