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CLEARFIL MAJESTY Flow (OA3)
EUDAMEDClass IIa (EU MDR)
Ref #2632-EUModel Composites
Identity
- Trade Name
- CLEARFIL MAJESTY Flow (OA3) EUDAMED
- Model / Reference
- Composites EUDAMED#2632-EU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04582110786327 EUDAMED
- Basic UDI-DI
- 458211076Composite132Z5 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
CLEARFIL MAJESTY Flow (OA3) by Kuraray Noritake Dental Inc. Kurashiki — 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 | 458211076Composite132Z5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Kuraray Noritake Dental Inc. Kurashiki
- EUDAMED SRN
- JP-MF-000017326
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 9528e808-1d87-48c7-8dd3-262abfd9bd38 61 fields · synced Jul 12, 2026