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Automix Syringe Mix Tips & Introral Tips
EUDAMEDClass I (EU MDR)
Ref 100906Ref 100117Ref 100911
Identity
- Trade Name
- Automix Syringe Mix Tips & Introral Tips EUDAMEDAutomix Syringe Mix Tips EUDAMED
- Device Name
- AUTOMIX TIPS & INTRAORAL TIPS EUDAMEDAUTOMIX SYRINGE TIPS EUDAMED
- Model / Reference
- 100906 EUDAMED100117 EUDAMED100911 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290115052763 EUDAMED07290115050639 EUDAMED07290115052831 EUDAMED
- Basic UDI-DI
- 729011505100911AC EUDAMED7290115051001179G EUDAMED
- Unit of Use DI
- 07290115051810 EUDAMED
- EMDN Code
- Q019006 DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
Automix Syringe Mix Tips & Introral Tips by B.J.M. Laboratories 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 | 729011505100911AC | Class I | Active |
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Manufacturer
- Manufacturer
- B.J.M. Laboratories Ltd.
- EUDAMED SRN
- IL-MF-000034121
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (3)
- EUDAMED d355cefd-def3-4117-9b33-21d08840bea7 61 fields · synced Jul 29, 2026
- EUDAMED a1fbcf7e-363c-4f21-baca-78df57fb3be3 61 fields · synced May 18, 2026
- EUDAMED d59b7511-5d80-4925-85bb-229457b9ec4c 61 fields · synced May 18, 2026