Identity
- Trade Name
- MEDIBASE EUDAMED
- Device Name
- MICRO APPLICATORS EUDAMED
- Model / Reference
- 3136865 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03665318009892 EUDAMED
- Basic UDI-DI
- 42504766MICUL EUDAMED
- EMDN Code
- Q019006 DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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 material injection cannula, single-use
Medibase is a Class I medical device used for implanting microapplicators. It has a standardized approach to testing and quality control, ensuring the highest level of sterility and safety. The device is designed for use in various clinical settings and is approved by regulatory bodies worldwide.
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Also classified as Dental material injection cannula, single-use.
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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 | 42504766MICUL | Class I | Active |
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Manufacturer
- Manufacturer
- Akzenta International SA
- EUDAMED SRN
- CH-MF-000036434
- Authorised Representative
- IQX GmbH AT-AR-000016713
Sources (1)
- EUDAMED f2299781-7c5a-4001-90d5-9005fd10a5d8 61 fields · synced Jun 27, 2026