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Regular/ Wide Implant 5.5mmD Sleeve
EUDAMEDClass I (EU MDR)
Ref MGST0055Model Guided Sleeve
Identity
- Trade Name
- Regular/ Wide Implant 5.5mmD Sleeve EUDAMED
- Model / Reference
- Guided Sleeve EUDAMEDMGST0055 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260525163918 EUDAMED
- Basic UDI-DI
- 426052516GuideSurgerTol3Z EUDAMED
- EMDN Code
- Q010280 PROSTHETIC DENTISTRY DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Regular/ Wide Implant 5.5mmD Sleeve by Medigma Biomedical Gmbh — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 426052516GuideSurgerTol3Z | Class I | Active |
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Manufacturer
- Manufacturer
- Medigma Biomedical Gmbh
- EUDAMED SRN
- DE-MF-000009412
Sources (1)
- EUDAMED 09900392-4a9a-4ce5-9f48-5be5293cee9b 61 fields · synced Jun 19, 2026