Identity
- Trade Name
- Pre-Sintered Zirconia Coloring Liquid EUDAMED
- Device Name
- Pre-Sintered Zirconia Coloring Liquid EUDAMED
- Model / Reference
- B3 20ml EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06932195327911 EUDAMED
- Basic UDI-DI
- 697558188RSY0708C6 EUDAMED
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMEDEUDAMED
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
Pre-Sintered Zirconia Coloring Liquid by Chengdu Besmile Medical Technology 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 | 697558188RSY0708C6 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Chengdu Besmile Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000025929
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (2)
- EUDAMED e07c59f4-52d4-4925-8921-9f25b1ac7807 61 fields · synced Jun 19, 2026
- EUDAMED 6725afdc-5a8c-49b8-8e8d-5ec03e812e4e 61 fields · synced Jun 19, 2026