Identity
- Trade Name
- Atlas FDA UDI
- Generic Name
- Automated lensmeter FDA UDI
- Device Name
- Automated AC powered Ophthalmic Lens Analyser for use in the testing and verification of semi finished and finished unmounted ophthalmic lenses FDA UDI
- Model / Reference
- Global FDA UDI
- Description
- Automated AC powered Ophthalmic Lens Analyser for use in the testing and verification of semi finished and finished unmounted ophthalmic lenses FDA UDI
Identifiers
- Catalog Number
- 3-004-0003-01 FDA UDI
- Primary DI / UDI-DI
- 05070000542829 FDA UDI
- FDA Product Code
- HLM FDA UDI
- GMDN Term
- Automated lensmeter FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.1425 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Automated lensmeter
Atlas by Eyoto, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- AUTO LENSMETER — Tomey Corporation · Class I
- TIANNUO / TNMED — Lianyungang Tiannuo Optical Instrument Co., Ltd. · Class I
- AUTO LENSMETER — Tomey Corporation · Class I
- VISIONIX — LUNEAU TECHNOLOGY OPERATIONS · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Eyoto, Inc.
Sources (1)
- FDA UDI 18e6b827-0564-4ecb-962e-875c9721c1ad 35 fields · synced May 30, 2026