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Crown Cutter Carbide
EUDAMEDClass IIa (EU MDR)
Ref H4MC.314.012.R0Ref H40.314.012.R0Ref H4MCL.314.012.R0Ref H4MCXL.314.014.R0Ref H4MCL.314.010.R0Ref H4MCXXL.314.014.R0Ref H35L.314.012.R0Ref H34.314.010.R0
Identity
- Device Name
- Crown Cutter Carbide EUDAMED
- Model / Reference
- H4MC.314.012.R0 EUDAMEDH40.314.012.R0 EUDAMEDH4MCL.314.012.R0 EUDAMEDH4MCXL.314.014.R0 EUDAMEDH4MCL.314.010.R0 EUDAMEDH4MCXXL.314.014.R0 EUDAMEDH35L.314.012.R0 EUDAMEDH34.314.010.R0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +E226031354R01 EUDAMED+E226035410R01 EUDAMED+E226031355R01 EUDAMED+E226036498R01 EUDAMED+E226034828R01 EUDAMED+E226039393R01 EUDAMED+E226045182R01 EUDAMED+E226018172R01 EUDAMED
- Basic UDI-DI
- ++E226532797CSMA EUDAMED
- Unit of Use DI
- +E226031354R08 EUDAMED+E226035410R08 EUDAMED+E226031355R08 EUDAMED+E226036498R08 EUDAMED+E226034828R08 EUDAMED+E226039393R08 EUDAMED+E226045182R08 EUDAMED+E226018172R08 EUDAMED
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
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
Crown Cutter Carbide by Gebr. Brasseler GmbH & Co. KG — 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 | ++E226532797CSMA | Class IIa | Active |
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Manufacturer
- Manufacturer
- Gebr. Brasseler GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000006446
Sources (8)
- EUDAMED d38460d8-2dc4-436d-bf40-a8555fceaa61 61 fields · synced Oct 6, 2026
- EUDAMED 0c6ba768-d7fb-4fe1-90c6-cd7fca5b88d6 61 fields · synced May 16, 2026
- EUDAMED d96e9c19-381f-463d-9c80-8197c7cc6ef7 61 fields · synced May 16, 2026
- EUDAMED f780f5bc-3bd6-4aa7-99f2-adda49e47823 61 fields · synced May 17, 2026
- EUDAMED 99aa1fba-56ca-4566-aeb1-ef60ab88d8ae 61 fields · synced May 17, 2026
- EUDAMED 5f616ca8-8ce0-43cf-a3f0-21cbda834d3a 61 fields · synced May 18, 2026
- EUDAMED a2514e06-c529-46e0-92a8-899a015756f0 61 fields · synced May 18, 2026
- EUDAMED 050cbb15-014c-4b65-998f-154d07e3b8cb 61 fields · synced May 18, 2026