Identity
- Model / Reference
- Nt-D Solution Resin EUDAMED03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809572568565 EUDAMED
- Basic UDI-DI
- 880957256DS01M7 EUDAMED
- Direct Marketing DI
- 08809572568565 EUDAMED
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa 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
03 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 | 880957256DS01M7 | 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 337a7451-8e69-4e1f-aab9-c074cd29aeee 61 fields · synced Jun 18, 2026