Identity
- Trade Name
- Lensmeter FDA UDI
- Generic Name
- Automated lensmeter FDA UDI
- Device Name
- It is mainly used to measure the vertex power and prism power of various spectacle lenses, determine the position and direction of the column lens axis, print marks on the unprocessed lens, and check whether the lens are correctly installed in the frame FDA UDI
- Model / Reference
- SK-1000B FDA UDI
- Description
- It is mainly used to measure the vertex power and prism power of various spectacle lenses, determine the position and direction of the column lens axis, print marks on the unprocessed lens, and check whether the lens are correctly installed in the frame FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973211070695 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
Lensmeter by Chongqing Sunkingdom Medical Instrument Co., Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Automated lensmeter.
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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
- Chongqing Sunkingdom Medical Instrument Co., Ltd
Sources (1)
- FDA UDI 1209c1f0-d80b-4515-ac5d-63c4b9bd7096 33 fields · synced May 30, 2026