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Drill S-5.5, 4.6/3.85mmDx8.0mmL
EUDAMEDClass IIa (EU MDR)
Ref MGSD0846Model Guided Surgery Drills Model Dental Drill
Identity
- Trade Name
- Drill S-5.5, 4.6/3.85mmDx8.0mmL EUDAMED
- Device Name
- Dental Drill EUDAMED
- Model / Reference
- Guided Surgery Drills EUDAMEDMGSD0846 EUDAMEDDental Drill EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260525163994 EUDAMEDD-DEMF000009412MGSD08462J EUDAMED
- Basic UDI-DI
- 426052516GuidDrillYD EUDAMEDB-DEMF000009412MGSD08462J EUDAMED
- EMDN Code
- Z12110102 DENTAL DRILLS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMEDTürkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMEDEUDAMED
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
Drill S-5.5, 4.6/3.85mmDx8.0mmL by Medigma Biomedical Gmbh — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 426052516GuidDrillYD | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | 426052516GuidDrillYD | Class IIa | Active |
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Manufacturer
- Manufacturer
- Medigma Biomedical Gmbh
- EUDAMED SRN
- DE-MF-000009412
Sources (2)
- EUDAMED ed6bb7a6-1c50-4acc-84c8-5e2b9a87a832 61 fields · synced Oct 6, 2026
- EUDAMED 737e4f57-91a0-4f8d-a432-6b956134f766 61 fields · synced May 16, 2026