Identity
- Trade Name
- NT Varnish EUDAMED
- Device Name
- Desensitizers(Varnish) EUDAMED
- Model / Reference
- Desensitizers(Varnish) EUDAMED05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809572561122 EUDAMED
- Basic UDI-DI
- 880957256DV01MN EUDAMED
- EMDN Code
- Q019008 DENTINAL DESENSITISERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Bulgaria 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
NT Varnish by Denbio Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Unknown
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 880957256DV01MN | Class IIa | Unknown |
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Manufacturer
- Manufacturer
- Denbio Co., Ltd.
- EUDAMED SRN
- KR-MF-000008327
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (1)
- EUDAMED 3b465f23-dd4f-4969-9f55-2113891b1ed6 61 fields · synced Jun 18, 2026