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ZENCHROMA - Universal Composite Refill
EUDAMEDClass IIa (EU MDR)
Ref PRD.100.01.ZENCHRM.UNI
Identity
- Trade Name
- ZENCHROMA - Universal Composite Refill EUDAMED
- Device Name
- ZENCHROMA - Universal Composite Refill EUDAMED
- Model / Reference
- PRD.100.01.ZENCHRM.UNI EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260296270129 EUDAMED
- Basic UDI-DI
- 426029627COM0033C 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
Category: Dental composite resin
ZENCHROMA - Universal Composite Refill by President Dental GmbH — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 426029627COM0033C | Class IIa | Active |
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Manufacturer
- Manufacturer
- President Dental GmbH
- EUDAMED SRN
- DE-MF-000014901
Sources (1)
- EUDAMED 06902ffb-661a-44c9-8d47-b19ef5a34c42 61 fields · synced Oct 8, 2026