Identity
- Trade Name
- Shade Plus DMLW16 EUDAMED
- Device Name
- Dental ceramic block for artificial tooth prostheses EUDAMED
- Model / Reference
- DMLW16 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800155210284 EUDAMED
- Basic UDI-DI
- 88001552SP00ML 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
Shade Plus DMLW16 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 | 88001552SP00ML | 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 e4b9b153-c755-4946-a3fd-6d7d4488ccbc 61 fields · synced Jun 19, 2026