Identity
- Trade Name
- AUTO LENSMETER FDA UDI
- Generic Name
- Manually-adjusted lensmeter, line-powered FDA UDI
- Device Name
- TL-6800 Auto lensmeter Hartmann sensor with 145 measurement points, ensures better result for progressive and multi-focus recognition and more accurate results Green spectral measurement light source Higher level hardware, good tracing performance of the optical system and faster measurement speed Can measure lens of low transmittance rate no less than 5% , sun glasses with dark color, tinted lens and polarized lens UV measurement Humanized design, tiltable screen, comfortable operation and easier for observation Data can be transferred to auto phoropter FDA UDI
- Model / Reference
- TL-6800 FDA UDI
- Description
- TL-6800 Auto lensmeter Hartmann sensor with 145 measurement points, ensures better result for progressive and multi-focus recognition and more accurate results Green spectral measurement light source Higher level hardware, good tracing performance of the optical system and faster measurement speed Can measure lens of low transmittance rate no less than 5% , sun glasses with dark color, tinted lens and polarized lens UV measurement Humanized design, tiltable screen, comfortable operation and easier for observation Data can be transferred to auto phoropter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971821408020 FDA UDI
- FDA Product Code
- HLM FDA UDI
- GMDN Term
- Manually-adjusted lensmeter, line-powered FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.1425 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
Auto Lensmeter by Ningbo Ming Sing Optical R & D Co., Ltd. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ningbo Ming Sing Optical R & D Co., Ltd.
Sources (2)
- FDA UDI 16348550-73ae-480e-9cf9-46f2be3bdd2c 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 5, 2026