Identity
- Trade Name
- NeoShine EUDAMED
- Device Name
- Dental Polishers – Sterile EUDAMED
- Model / Reference
- NS-CP DISC 14 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00818963024403 EUDAMED
- Basic UDI-DI
- 081896302NSMLE EUDAMED
- EMDN Code
- Q010503 IMPRESSION MATERIAL TRAYS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa 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
Category: Dental impression tray, single-use
NeoShine by Microcopy, A Division of Neo-Flo, Inc. — 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 | 081896302NSMLE | Class IIa | Active |
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Manufacturer
- Manufacturer
- Microcopy, A Division of Neo-Flo, Inc.
- EUDAMED SRN
- US-MF-000012637
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED d7cdf4de-9c3a-4e58-bf78-aa3463a65c68 61 fields · synced Jul 23, 2026