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MB Guided Surgery Tools Kit - IHX Implants
EUDAMEDClass IIa (EU MDR)
Ref MGSK003Model KitModel Tools
Identity
- Trade Name
- MB Guided Surgery Tools Kit - IHX Implants EUDAMED
- Device Name
- Tools EUDAMED
- Model / Reference
- Kit EUDAMEDMGSK003 EUDAMEDTools EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260525164267 EUDAMEDD-DEMF000009412MGSK003ES EUDAMED
- Basic UDI-DI
- 426052516FullKitFK EUDAMEDB-DEMF000009412MGSK003ES EUDAMED
- EMDN Code
- L159016 DENTAL SURGERY INSTRUMENT KITS, REUSABLE EUDAMEDZ12110180 INSTRUMENTS FOR DENTAL TREATMENT UNITS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa 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
Category: Dental/maxillofacial surgical procedure kit, non-medicated, reusable
MB Guided Surgery Tools Kit - IHX Implants by Medigma Biomedical Gmbh — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Dental/maxillofacial surgical procedure kit, non-medicated, reusable.
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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 | 426052516FullKitFK | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 426052516FullKitFK | Class IIa | Active |
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Manufacturer
- Manufacturer
- Medigma Biomedical Gmbh
- EUDAMED SRN
- DE-MF-000009412
Sources (2)
- EUDAMED 169291aa-ea2b-49e2-9fbd-01d2530e6d15 61 fields · synced Oct 6, 2026
- EUDAMED cbb09bea-4095-4db5-85ca-ccbbc8bf9bbe 61 fields · synced May 18, 2026