Identity
- Trade Name
- Intraoral Dispensing Tips EUDAMED
- Device Name
- INTRAORAL TIPS EUDAMED
- Model / Reference
- 400191YIOT50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290115052701 EUDAMED
- Basic UDI-DI
- 729011505400193B7 EUDAMED
- Unit of Use DI
- 07290115052497 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
Intraoral Dispensing Tips by B.J.M. Laboratories Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 729011505400193B7 | 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 (1)
- EUDAMED e35c65f3-309b-4b06-b725-768cec837bc6 61 fields · synced Jun 20, 2026