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FixTite™-S spiral Dental Implant S 5.0D 16L
EUDAMEDClass IIb (EU MDR)
Ref 50161Model FixTite-S Implant
Identity
- Trade Name
- FixTite™-S spiral Dental Implant S 5.0D 16L EUDAMED
- Device Name
- FixTite-S Implant EUDAMED
- Model / Reference
- FixTite-S Implant EUDAMED50161 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-DEMF00000941250161HL EUDAMED
- Basic UDI-DI
- B-DEMF00000941250161HL EUDAMED
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
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
FixTite™-S spiral Dental Implant S 5.0D 16L by Medigma Biomedical Gmbh — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-DEMF00000941250161HL | Class IIb | Active |
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Manufacturer
- Manufacturer
- Medigma Biomedical Gmbh
- EUDAMED SRN
- DE-MF-000009412
Sources (1)
- EUDAMED e51431b4-ed53-424c-8f01-03ab04cd0816 61 fields · synced Oct 6, 2026