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One Piece Implant 4.2D 15L
EUDAMEDClass IIb (EU MDR)
Ref FO-4215Model One Piece Implant
Identity
- Trade Name
- One Piece Implant 4.2D 15L EUDAMED
- Device Name
- One Piece Implant EUDAMED
- Model / Reference
- One Piece Implant EUDAMEDFO-4215 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-DEMF000009412FO4215FF EUDAMED
- Basic UDI-DI
- B-DEMF000009412FO4215FF 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
One Piece Implant 4.2D 15L 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-DEMF000009412FO4215FF | Class IIb | Active |
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Manufacturer
- Manufacturer
- Medigma Biomedical Gmbh
- EUDAMED SRN
- DE-MF-000009412
Sources (1)
- EUDAMED 0b206350-6487-4364-94e4-50a3c9b9029f 61 fields · synced Jun 18, 2026