Identity
- Trade Name
- 4mm super fine, 1S, diamond, perforated EUDAMED
- Device Name
- Abrasive Strips EUDAMED
- Model / Reference
- 46050 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +J01046050 EUDAMED
- Basic UDI-DI
- ++J010ABRASIVESTRIPSW8 EUDAMED
- EMDN Code
- Q01010403 DENTAL ABRASIVE AND POLISHING MATERIALS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
4mm super fine, 1S, diamond, perforated by Produits Dentaires SA — 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 | ++J010ABRASIVESTRIPSW8 | Class I | Active |
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Manufacturer
- Manufacturer
- Produits Dentaires SA
- EUDAMED SRN
- CH-MF-000023147
- Authorised Representative
- PD DENTAL EU SAS FR-AR-000017144
Sources (1)
- EUDAMED d4250df0-8f19-4b8d-b543-4736a19f4f17 61 fields · synced Jul 10, 2026