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Micro applicator
EUDAMEDClass I (EU MDR)
Ref TA026AModel TA026A-1、TA026A-2、TA026A-3、TA026A-4
Identity
- Trade Name
- Micro applicator EUDAMED
- Device Name
- Micro Applicator EUDAMED
- Model / Reference
- TA026A-1、TA026A-2、TA026A-3、TA026A-4 EUDAMEDTA026A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974843126019 EUDAMED
- Basic UDI-DI
- 697484312TA026AF5 EUDAMED
- EMDN Code
- Q019006 DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark 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
Micro applicator by ZOGEAR Medical Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697484312TA026AF5 | Class I | Active |
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Manufacturer
- Manufacturer
- ZOGEAR Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000012353
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED 74657e16-a86f-42ec-a4f4-10dd9c0f3222 61 fields · synced Jul 8, 2026