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ZENIT - LC Nano Ceramic Composite Refill Syringe ER (Effect Masses ) RED
EUDAMEDClass IIa (EU MDR)
Ref PRD.100.01.ZN16
Identity
- Trade Name
- ZENIT - LC Nano Ceramic Composite Refill Syringe ER (Effect Masses ) RED EUDAMED
- Device Name
- ZENIT - LC Nano Ceramic Composite Refill Syringe EUDAMED
- Model / Reference
- PRD.100.01.ZN16 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260296271638 EUDAMED
- Basic UDI-DI
- 426029627COM00138 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
ZENIT - LC Nano Ceramic Composite Refill Syringe ER (Effect Masses ) RED by President Dental GmbH — Class IIa — MDR — listed in EUDAMED
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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 | 426029627COM00138 | Class IIa | Active |
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Manufacturer
- Manufacturer
- President Dental GmbH
- EUDAMED SRN
- DE-MF-000014901
Sources (1)
- EUDAMED bd3ed270-b4d7-4798-9c4e-b333ce994428 61 fields · synced Jun 20, 2026