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One Piece Screw-in Abutment
EUDAMEDClass IIb (EU MDR)
Ref OPAModel Dental Abutment
Identity
- Trade Name
- One Piece Screw-in Abutment EUDAMED
- Device Name
- Dental Abutment EUDAMED
- Model / Reference
- Dental Abutment EUDAMEDOPA EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-DEMF000009412OPAAT EUDAMED
- Basic UDI-DI
- B-DEMF000009412OPAAT EUDAMED
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
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
One Piece Screw-in Abutment 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-DEMF000009412OPAAT | Class IIb | Active |
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Manufacturer
- Manufacturer
- Medigma Biomedical Gmbh
- EUDAMED SRN
- DE-MF-000009412
Sources (1)
- EUDAMED eb69167f-eb67-475e-b08e-a3895549ca49 61 fields · synced Jun 19, 2026