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Ratchet 4mm Hex
EUDAMEDClass I (EU MDR)
Ref MGST0010Model Guided SleeveModel Dental Accessory
Identity
- Trade Name
- Ratchet 4mm Hex EUDAMED
- Device Name
- Dental Accessory EUDAMED
- Model / Reference
- Guided Sleeve EUDAMEDMGST0010 EUDAMEDDental Accessory EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260525163765 EUDAMEDD-DEMF000009412MGST001065 EUDAMED
- Basic UDI-DI
- 426052516GuideSurgerTol3Z EUDAMEDB-DEMF000009412MGST001065 EUDAMED
- EMDN Code
- Q010280 PROSTHETIC DENTISTRY DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I 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
Ratchet 4mm Hex by Medigma Biomedical Gmbh — Class I — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 426052516GuideSurgerTol3Z | Class I | Active |
| EUDAMED | European Union | CE/MDR | 426052516GuideSurgerTol3Z | Class I | Active |
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Manufacturer
- Manufacturer
- Medigma Biomedical Gmbh
- EUDAMED SRN
- DE-MF-000009412
Sources (2)
- EUDAMED cdce6c1e-c38c-4daf-b037-fce0bc8ad76e 61 fields · synced Oct 5, 2026
- EUDAMED 33f8fca8-dc75-41ee-8f04-754b6c36a4ce 61 fields · synced May 18, 2026