Identity
- Trade Name
- DMAX Coloring Liquid 2L1.5-20ml EUDAMED
- Device Name
- Liquid Stain for dental zirconium prosthesis EUDAMED
- Model / Reference
- 2L1.5-20ml EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809542034564 EUDAMED
- Basic UDI-DI
- 880954203LD00FP EUDAMED
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
DMAX Coloring Liquid 2L1.5-20ml by DMAX Co., Ltd. — Class IIa — 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 | 880954203LD00FP | Class IIa | Active |
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Manufacturer
- Manufacturer
- DMAX Co., Ltd.
- EUDAMED SRN
- KR-MF-000020635
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 8db823e6-1397-434a-8260-7fd920f7d253 61 fields · synced Jun 19, 2026