Identity
- Trade Name
- N-Etch Refill 2x2 g EUDAMED
- Device Name
- Eco-Etch, N-Etch, Total Etch EUDAMED
- Model / Reference
- 630210AN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07615208297393 EUDAMED
- Basic UDI-DI
- 76152082AETCH001J9 EUDAMED
- Unit of Use DI
- 07615208472509 EUDAMED
- EMDN Code
- Q01010402 ENAMEL-DENTINAL ETCHING MATERIALS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Liechtenstein 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
Category: Dental etching solution
N-Etch Refill 2x2 g by Ivoclar Vivadent AG — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 76152082AETCH001J9 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ivoclar Vivadent AG
- EUDAMED SRN
- LI-MF-000000522
Sources (1)
- EUDAMED 6af435ce-7817-4421-a021-a64f245605c6 61 fields · synced Jun 19, 2026