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ZENIT COLOR, Composite Refil - stains on composite basis, Blue (1gr)
EUDAMEDClass IIa (EU MDR)
Ref PRD.01.ZC100.BLU
Identity
- Trade Name
- ZENIT COLOR, Composite Refil - stains on composite basis, Blue (1gr) EUDAMED
- Device Name
- ZENIT COLOR, Composite EUDAMED
- Model / Reference
- PRD.01.ZC100.BLU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260296271331 EUDAMED
- Basic UDI-DI
- 426029627COM0043E EUDAMED
- EMDN Code
- Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
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
ZENIT COLOR, Composite Refil - stains on composite basis, Blue (1gr) by President Dental GmbH — Class IIa — MDR — listed in EUDAMED
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 | 426029627COM0043E | Class IIa | Active |
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Manufacturer
- Manufacturer
- President Dental GmbH
- EUDAMED SRN
- DE-MF-000014901
Sources (1)
- EUDAMED da038598-4815-4ae4-8ef0-0cd2c700e573 61 fields · synced Oct 7, 2026