Identity
- Trade Name
- ALADDIN HW3.0 FDA UDI
- Generic Name
- Corneal topography system analyser FDA UDI
- Model / Reference
- 1240212US FDA UDI
Identifiers
- Catalog Number
- 1240212US FDA UDI
- Primary DI / UDI-DI
- 08034028770333 FDA UDI
- 510(k) Number
- K160327 FDA UDI
- FDA Product Code
- HJO FDA UDI
- GMDN Term
- Corneal topography system analyser FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.1850 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Corneal topography system analyser
Aladdin Hw3.0 by Visia Imaging Srl — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Corneal topography system analyser.
- Corneal Topographer — CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO., LTD · Class I
- TearCheck T — E-Swin · Class I
- WAVE ANALYZER MEDICA 800 — ESSILOR INTERNATIONAL · Class II
- MOPTIM — Shenzhen CERTAINN Technology Co., Ltd. · Class I
- Corneal Topographer — CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO., LTD · Class I
- WAVE ANALYZER MEDICA 700 PLUS — ESSILOR INTERNATIONAL · Class II
- TearCheck T — E-Swin · Class I
- ALADDIN TMS — VISIA IMAGING SRL · Class II
Cleared under the same submission
K160327 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Visia Imaging Srl
Sources (2)
- FDA UDI d06ec361-5413-42a8-afe6-89d68242bfb8 34 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026