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ENDOCEM PREMIXED REGULAR(3 g)
EUDAMEDClass IIa (EU MDR)
Ref 00130Model ENDOCEM MTA PREMIXED REGULAR / SendoCem MTA
by Maruchi
Identity
- Trade Name
- ENDOCEM PREMIXED REGULAR(3 g) EUDAMED
- Device Name
- ENDOCEM MTA PREMIXED REGULAR EUDAMED
- Model / Reference
- ENDOCEM MTA PREMIXED REGULAR / SendoCem MTA EUDAMED00130 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800071200130 EUDAMED
- Basic UDI-DI
- 8800071200130UF EUDAMED
- EMDN Code
- Q01010201 ROOT CANAL FILLING DENTAL PASTES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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 coating, tooth-desensitizing
ENDOCEM PREMIXED REGULAR(3 g) by Maruchi — 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 | 8800071200130UF | Class IIa | Active |
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Manufacturer
- Manufacturer
- Maruchi
- EUDAMED SRN
- KR-MF-000030192
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (1)
- EUDAMED e418f93b-7c5a-4373-b830-c9afdb59edf9 61 fields · synced Jul 15, 2026