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Luzzani LU135 Pro-Tip Coverter Kit Cefla
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 116235CEFLA
Identity
- Trade Name
- Luzzani LU135 Pro-Tip Coverter Kit Cefla EUDAMEDAstek FDA UDI
- Generic Name
- Dental delivery system irrigation handpiece FDA UDI
- Device Name
- Luzzani LU135 Pro-Tip Coverter Kit Cefla EUDAMEDFDA UDI
- Model / Reference
- 116235CEFLA EUDAMEDFDA UDI
- Description
- Luzzani LU135 Pro-Tip Coverter Kit Cefla FDA UDI
Identifiers
- Catalog Number
- 116235CEFLA FDA UDI
- Primary DI / UDI-DI
- 10840326422028 EUDAMED00840326422021 FDA UDI
- Basic UDI-DI
- B-10840326422028 EUDAMED
- FDA Product Code
- ECB FDA UDI
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Dental delivery system irrigation handpiece FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Luzzani LU135 Pro-Tip Coverter Kit Cefla by Young Innovations, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-10840326422028 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Young Innovations Inc
- EUDAMED SRN
- US-MF-000017796
- Authorised Representative
- Young Microbrush Ireland Ltd IE-AR-000011249
Sources (2)
- EUDAMED 42e2f6a0-20a0-4925-8150-1b4296ebaf7c 61 fields · synced Jul 26, 2026
- FDA UDI 6e21e3f3-66f5-4a66-9353-a7f16dab6d88 35 fields · synced May 30, 2026