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Surgery Kit - Plastic Tray
EUDAMEDClass I (EU MDR)
Ref MIH6313Model Dental AccessoryModel Tray
Identity
- Trade Name
- Surgery Kit - Plastic Tray EUDAMED
- Device Name
- Dental Accessory EUDAMED
- Model / Reference
- Dental Accessory EUDAMEDMIH6313 EUDAMEDTray EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-DEMF000009412MIH63137Z EUDAMED04260525167442 EUDAMED
- Basic UDI-DI
- B-DEMF000009412MIH63137Z EUDAMED426052516EmptyKitDC EUDAMED
- EMDN Code
- S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye EUDAMEDGermany 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
Category: Instrument tray, reusable
Surgery Kit - Plastic Tray by Medigma Biomedical Gmbh — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Instrument tray, reusable.
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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-DEMF000009412MIH63137Z | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-DEMF000009412MIH63137Z | Class I | Active |
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Manufacturer
- Manufacturer
- Medigma Biomedical Gmbh
- EUDAMED SRN
- DE-MF-000009412
Sources (2)
- EUDAMED 3cb904da-8eab-4ae8-b03f-2a1f38ea2531 61 fields · synced Oct 6, 2026
- EUDAMED b35f23a1-65bb-4076-bc2c-e6c097397a7c 61 fields · synced May 19, 2026