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ENDOSEAL MTA(3 g)
EUDAMEDClass IIa (EU MDR)
Ref 04305Model ENDOSEAL MTA/ ENDOSEAL Bioceramic Sealer / SendoSeal MTA
by Maruchi
Identity
- Trade Name
- ENDOSEAL MTA(3 g) EUDAMED
- Device Name
- ENDOSEAL MTA EUDAMED
- Model / Reference
- ENDOSEAL MTA/ ENDOSEAL Bioceramic Sealer / SendoSeal MTA EUDAMED04305 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800071204305 EUDAMED
- Basic UDI-DI
- 8800071200000TZ EUDAMED
- EMDN Code
- Q01010201 ROOT CANAL FILLING DENTAL PASTES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Bulgaria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
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
ENDOSEAL MTA(3 g) by Maruchi — 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 | 8800071200000TZ | 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 8660f855-aa97-4e74-8df5-7e65353e77af 61 fields · synced Jun 18, 2026