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Mallet Assy, Grooved (S9KNEE Shukla Knee / Universal Knee Implant Extraction Sy…
EUDAMEDClass I (EU MDR)
Ref SMT001
Identity
- Trade Name
- Mallet Assy, Grooved (S9KNEE Shukla Knee / Universal Knee Implant Extraction System) EUDAMED
- Device Name
- Mallet Assy, Grooved (S9KNEE Shukla Knee / Universal Knee Implant Extraction System) EUDAMED
- Model / Reference
- SMT001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B756SMT0010 EUDAMED
- Basic UDI-DI
- ++B756S9KNEEMALC8 EUDAMED
- Direct Marketing DI
- +B756SMT0010 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
Mallet Assy, Grooved (S9KNEE Shukla Knee / Universal Knee Implant Extraction Sy… by S. S. White Technologies Inc/DBA Shukla Medical — Class I — MDR — listed…
Manufacturer's product page: Knee
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 | ++B756S9KNEEMALC8 | 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 224f1809-0579-4722-950f-b4c6c58699b0 61 fields · synced Oct 6, 2026