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ParaCore Slow Trans, 2 x 5 ml
EUDAMEDClass IIa (EU MDR)
Ref 60011392Model ParaCore
by Dent4You AG
Identity
- Trade Name
- ParaCore Slow Trans, 2 x 5 ml EUDAMED
- Model / Reference
- ParaCore EUDAMED60011392 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630243601301 EUDAMED
- Basic UDI-DI
- 76303929COMP201114F 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
ParaCore Slow Trans, 2 x 5 ml by Dent4You AG — 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 | 76303929COMP201114F | Class IIa | Active |
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Manufacturer
- Manufacturer
- Dent4You AG
- EUDAMED SRN
- CH-MF-000028926
- Authorised Representative
- Coltène/Whaledent GmbH + Co. KG DE-AR-000005719
Sources (1)
- EUDAMED 928199aa-bdd9-4b06-8ff4-cf317b1e1549 61 fields · synced Jul 30, 2026