Identity
- Trade Name
- KATANA Cleaner EUDAMED
- Model / Reference
- Cleaner EUDAMED#3970-EU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04582110799709 EUDAMED
- Basic UDI-DI
- B-04582110799709 EUDAMED458211076CleanerDJ EUDAMED
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
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 appliance fabrication material, ceramic
KATANA Cleaner by Kuraray Noritake Dental Inc. Kurashiki — Class IIa — MDR, MDD — 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
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04582110799709 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04582110799709 | 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 ac58b46a-4691-4ed1-bad6-f696d6f442ff 61 fields · synced May 24, 2026
- EUDAMED a4ece5fc-61fd-47e3-bf9d-5f7ba95a9aac 61 fields · synced May 19, 2026