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SD Fix Konisch™ Close Tray Transfer 4.2mmDx13mmL
EUDAMEDClass I (EU MDR)
Ref MSD5213Model Dental Accessory
Identity
- Trade Name
- SD Fix Konisch™ Close Tray Transfer 4.2mmDx13mmL EUDAMED
- Device Name
- Dental Accessory EUDAMED
- Model / Reference
- Dental Accessory EUDAMEDMSD5213 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-DEMF000009412MSD5213AB EUDAMED
- Basic UDI-DI
- B-DEMF000009412MSD5213AB EUDAMED
- EMDN Code
- Q010207 DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Category: Dental implant suprastructure, temporary, preformed, single-use
SD Fix Konisch™ Close Tray Transfer 4.2mmDx13mmL by Medigma Biomedical Gmbh — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Dental implant suprastructure, temporary, preformed, single-use.
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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-DEMF000009412MSD5213AB | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-DEMF000009412MSD5213AB | Class I | Active |
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Manufacturer
- Manufacturer
- Medigma Biomedical Gmbh
- EUDAMED SRN
- DE-MF-000009412
Sources (1)
- EUDAMED 8a8de36f-34c4-4c14-b824-20d31d3a3fc3 61 fields · synced Oct 6, 2026