Identity
- Trade Name
- 4mm Fine 1S Diamond finish with gap EUDAMED4mm Fine 1S EUDAMED
- Device Name
- Abrasive Strips EUDAMED
- Model / Reference
- 46026 EUDAMED46021 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +J01046026 EUDAMED+J01046021 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 Fine 1S Diamond finish with gap 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 (2)
- EUDAMED 4354a020-57a2-42cc-b909-cf189dfe9cd7 61 fields · synced Jul 18, 2026
- EUDAMED 123ed72e-2a35-4dd9-aca3-0ee29967e4ce 61 fields · synced May 18, 2026