Identity
- Trade Name
- ZerofloX EUDAMED
- Device Name
- Micro Applicator EUDAMED
- Model / Reference
- 189454 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640253167766 EUDAMED
- Basic UDI-DI
- ++D089MicroApplicatorG6 EUDAMED
- Unit of Use DI
- 07640253163867 EUDAMED
- EMDN Code
- Q019006 DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I 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
ZerofloX by medmix Switzerland AG — Class I — 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 | ++D089MicroApplicatorG6 | Class I | Active |
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Manufacturer
- Manufacturer
- medmix Switzerland AG
- EUDAMED SRN
- CH-MF-000016467
- Authorised Representative
- medmix Deutschland GmbH DE-AR-000014060
Sources (1)
- EUDAMED c2cf4470-291b-4dbe-868c-a6f971860c7d 61 fields · synced Jun 18, 2026