← Back to catalogue
Twist Step Drill 3.8/4.2mmD x 8-18mmL
EUDAMEDClass IIa (EU MDR)
Ref 1842DMModel Twist Step DrillRef 1342DMModel Dental Drills
Identity
- Trade Name
- Twist Step Drill 3.8/4.2mmD x 8-18mmL EUDAMEDTwist Step Drill 3.8/4.2mmD x 6-13mmL EUDAMED
- Device Name
- Twist Step Drill EUDAMEDDental Drills EUDAMED
- Model / Reference
- Twist Step Drill EUDAMED1842DM EUDAMED1342DM EUDAMEDDental Drills EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-DEMF0000094121842DM2V EUDAMED04260525160702 EUDAMEDD-DEMF0000094121342DMZ3 EUDAMED
- Basic UDI-DI
- B-DEMF0000094121842DM2V EUDAMED426052516TwistStepDrill8Z EUDAMEDB-DEMF0000094121342DMZ3 EUDAMED
- EMDN Code
- Z12110102 DENTAL DRILLS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Twist Step Drill 3.8/4.2mmD x 8-18mmL 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 | B-DEMF0000094121842DM2V | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-DEMF0000094121842DM2V | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medigma Biomedical Gmbh
- EUDAMED SRN
- DE-MF-000009412
Sources (3)
- EUDAMED 923656f0-848e-493b-90b2-159ceb57e168 61 fields · synced Oct 6, 2026
- EUDAMED bf160a7b-5111-4da4-95b2-d208104957c8 61 fields · synced May 18, 2026
- EUDAMED 33c9fb26-1d06-4521-89f3-14b86c0773c6 61 fields · synced May 19, 2026