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SD Fix Konisch™ Open Tray Transfer 4.2mmDx14mmL
EUDAMEDClass I (EU MDR)
Ref MSD5514Model Dental AccessoryModel Dental Tray Transfer
Identity
- Trade Name
- SD Fix Konisch™ Open Tray Transfer 4.2mmDx14mmL EUDAMED
- Device Name
- Dental Accessory EUDAMED
- Model / Reference
- Dental Accessory EUDAMEDMSD5514 EUDAMEDDental Tray Transfer EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-DEMF000009412MSD5514AU EUDAMED04260525166735 EUDAMED
- Basic UDI-DI
- B-DEMF000009412MSD5514AU EUDAMED426052516OpenTrayTranXJ EUDAMED
- EMDN Code
- Q010207 DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye EUDAMEDGermany 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™ Open Tray Transfer 4.2mmDx14mmL by Medigma Biomedical Gmbh — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, temporary, preformed, single-use.
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- Falcon — Falcon Surgical Co. (Pvt.) Ltd · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Neoss Implant System — Neoss, Ltd. · Class II
- Scanbody Screw — ARUM DENTISTRY Co., Ltd. · Class I
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-DEMF000009412MSD5514AU | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-DEMF000009412MSD5514AU | Class I | Active |
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Manufacturer
- Manufacturer
- Medigma Biomedical Gmbh
- EUDAMED SRN
- DE-MF-000009412
Sources (2)
- EUDAMED cf6f6a5e-30d1-4a76-8625-d2d4f86a3331 61 fields · synced Oct 6, 2026
- EUDAMED 9ee665d8-9777-45d4-88da-aacd0935a646 61 fields · synced May 19, 2026