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Mallet Assy, Big (Shukla Knee S9KNEE, Shukla Nail S9NAIl Implant Extraction Sys…
EUDAMEDClass I (EU MDR)
Ref SMT002
Identity
- Trade Name
- Mallet Assy, Big (Shukla Knee S9KNEE, Shukla Nail S9NAIl Implant Extraction Systems) EUDAMED
- Device Name
- Mallet Assy, Big (Shukla Knee S9KNEE, Shukla Nail S9NAIL Implant Extraction Systems) EUDAMED
- Model / Reference
- SMT002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B756SMT0020 EUDAMED
- Basic UDI-DI
- ++B756SMT002ZJ EUDAMED
- Direct Marketing DI
- +B756SMT0020 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, Big (Shukla Knee S9KNEE, Shukla Nail S9NAIl Implant Extraction Sys… by S. S. White Technologies Inc/DBA Shukla Medical — Class I — MDR — listed…
Manufacturer's product page: SHUKLA Trauma Maxi
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 | ++B756SMT002ZJ | 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 b5ea8aa1-322e-4cd6-ad7e-45670e083d6a 61 fields · synced Oct 5, 2026