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OneTM Implant Analog 4.2D, Machined
EUDAMEDClass I (EU MDR)
Ref RO0042Model Analog
Identity
- Trade Name
- OneTM Implant Analog 4.2D, Machined EUDAMED
- Model / Reference
- Analog EUDAMEDRO0042 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290116770222 EUDAMED
- Basic UDI-DI
- 729011677ImplantianalgPV EUDAMED
- EMDN Code
- Q010207 DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY 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
OneTM Implant Analog 4.2D, Machined by Adin Dental Implant Systems Ltd. — 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 | 729011677ImplantianalgPV | Class I | Active |
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Manufacturer
- Manufacturer
- Adin Dental Implant Systems LTD.
- EUDAMED SRN
- IL-MF-000014625
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 5dfdd723-a6db-4324-a06d-f355cef494e9 61 fields · synced Jun 18, 2026