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CLEARFIL MAJESTY ES Flow Universal Super Low (U)
EUDAMEDClass IIa (EU MDR)
Ref #4620-EUModel CompositesRef #4622-EU
Identity
- Trade Name
- CLEARFIL MAJESTY ES Flow Universal Super Low (U) EUDAMEDCLEARFIL MAJESTY ES Flow Universal Super Low (U) TRIAL EUDAMED
- Model / Reference
- Composites EUDAMED#4620-EU EUDAMED#4622-EU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04582110806209 EUDAMED04582110806223 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 Super Low (U) 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 2d43cc43-5396-4ecd-95f3-149a9a7b1337 61 fields · synced Jul 21, 2026
- EUDAMED 33a2ca43-b839-49c8-908f-7020253f0646 61 fields · synced May 17, 2026