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CLEARFIL MAJESTY ES Flow Universal Low (UD)
EUDAMEDClass IIa (EU MDR)
Ref #4601-EUModel CompositesRef #4609-EU
Identity
- Trade Name
- CLEARFIL MAJESTY ES Flow Universal Low (UD) EUDAMEDCLEARFIL MAJESTY ES Flow Universal Low (UD) TRIAL EUDAMED
- Model / Reference
- Composites EUDAMED#4601-EU EUDAMED#4609-EU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04582110806018 EUDAMED04582110806094 EUDAMED
- Basic UDI-DI
- 458211076CompositeKS 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
CLEARFIL MAJESTY ES Flow Universal Low (UD) by Kuraray Noritake Dental Inc. Kurashiki — 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 | 458211076CompositeKS | 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 (2)
- EUDAMED 635a805c-76be-41f2-81db-6c0449918e97 61 fields · synced Aug 2, 2026
- EUDAMED 50962e67-92c3-441b-b2c7-bee237862d95 61 fields · synced May 18, 2026