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Aladdin Hw3.0
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 1240212Model ALADDIN HW3.0510(k) K131567Ref TEM1240212EX
Identity
- Trade Name
- ALADDIN HW3.0 EUDAMEDFDA UDI
- Generic Name
- Corneal topography system analyser FDA UDI
- Device Name
- ALADDIN HW3.0 EUDAMED
- Model / Reference
- ALADDIN HW3.0 EUDAMED1240212 EUDAMEDTEM1240212EX EUDAMEDFDA UDI
Identifiers
- Catalog Number
- TEM1240212EX FDA UDI
- Primary DI / UDI-DI
- 08034028770203 EUDAMEDFDA UDI08034028770494 EUDAMED
- Basic UDI-DI
- 803402877BIOMETER1C5 EUDAMED
- 510(k) Number
- K160327 FDA UDI
- FDA Product Code
- HJO FDA UDI
- EMDN Code
- Z12120102 COMPUTERISED OPTICAL BIOMETERS EUDAMED
- GMDN Term
- Corneal topography system analyser FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1850 FDA UDI
- Market of Registration
- Italy 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
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Aladdin Hw3.0 by Visia Imaging Srl — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K131567 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K160327 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 803402877BIOMETER1C5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Visia imaging SRL
- EUDAMED SRN
- IT-MF-000015628
- FDA Applicant
- Visia Imaging S.R.L.
Sources (4)
- EUDAMED 392f48f0-f86d-45f1-a3fb-a10bd27885b6 85 fields · synced Jun 19, 2026
- EUDAMED f742a9e8-6a5e-4a83-8d03-0c1260416b87 61 fields · synced May 17, 2026
- FDA UDI c798a634-49ad-46c3-a673-0cb778225ccb 34 fields · synced May 29, 2026
- FDA 510(k) K131567 1 fields · synced May 18, 2026