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Luzzani LU146 Pro-Tip Converter Kit Astek
EUDAMEDClass IIa (EU MDR)
Ref 116342ASTEK
Identity
- Trade Name
- Luzzani LU146 Pro-Tip Converter Kit Astek EUDAMED
- Device Name
- Luzzani LU146 Pro-Tip Converter Kit Astek EUDAMED
- Model / Reference
- 116342ASTEK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10840326422066 EUDAMED
- Basic UDI-DI
- B-10840326422066 EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Luzzani LU146 Pro-Tip Converter Kit Astek by Young Innovations, Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-10840326422066 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Young Innovations Inc
- EUDAMED SRN
- US-MF-000017796
- Authorised Representative
- Young Microbrush Ireland Ltd IE-AR-000011249
Sources (1)
- EUDAMED d9b4d0dc-439a-48a0-87ae-280e83725f74 61 fields · synced Jul 21, 2026