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Endodontic Irrigation Tips
EUDAMEDClass I (EU MDR)
Ref 400095XL50Ref 400092XL50Ref 400092XL50IT
Identity
- Trade Name
- Endodontic Irrigation Tips EUDAMED
- Device Name
- DISPENSING TIPS EUDAMED
- Model / Reference
- 400095XL50 EUDAMED400092XL50 EUDAMED400092XL50IT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290115050707 EUDAMED07290115050684 EUDAMED07290115051735 EUDAMED
- Basic UDI-DI
- 729011505400094B4 EUDAMED
- Unit of Use DI
- 07290115052480 EUDAMED07290115052459 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
Endodontic Irrigation 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 | 729011505400094B4 | 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 a50230cf-e407-47dd-9975-e7cddb997ed9 61 fields · synced Aug 1, 2026
- EUDAMED 9ad90e44-554d-4568-adb7-40d97cafa91e 61 fields · synced May 17, 2026
- EUDAMED b650459d-41f2-4c11-b224-e3323b7442c1 61 fields · synced May 18, 2026