GUANGZHOU MECAN MEDICAL LTD · 89-08 · CHINA
For GUANGZHOU MECAN MEDICAL LTD, import alert is 89-08; country is CHINA; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; product is Rebound Tonometer | Rebound Tonometer | Rebound Tonometer | Rebound Tonometer; product code is 86 H - - KX Tonometer, Ac-Powered | 86 H - - KY Tonometer, Manual | 86 H - - KZ Sterilizer, Tonometer | 86 H - - OY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear and Post-Mydriatic Eyewear); date published is 09/02/2020; address is RM 718, YIDONG BLDG., X , GUANGZHOU, CHINA, verified against its source on 2026-09-30.
- Firm
- GUANGZHOU MECAN MEDICAL LTD verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- CHINA verified
- Address
- RM 718, YIDONG BLDG., X , GUANGZHOU, CHINA verified
- Date published
- 09/02/2020 verified
- Product code
- 86 H - - KX Tonometer, Ac-Powered | 86 H - - KY Tonometer, Manual | 86 H - - KZ Sterilizer, Tonometer | 86 H - - OY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear and Post-Mydriatic Eyewear) each item verified
- Product
- Rebound Tonometer | Rebound Tonometer | Rebound Tonometer | Rebound Tonometer each item verified
What the source says
GUANGZHOU MECAN MEDICAL LTD Date Published : 09/02/2020 RM 718, YIDONG BLDG., X , GUANGZHOU, CHINA
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code and Product
86 H - - KX Tonometer, Ac-Powered Date Published: 09/02/2020 Desc: Rebound Tonometer 86 H - - KY Tonometer, Manual Date Published: 09/02/2020 Desc: Rebound Tonometer 86 H - - KZ Sterilizer, Tonometer Date Published: 09/02/2020 Desc: Rebound Tonometer 86 H - - OY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear and Post-Mydriatic Eyewear) Date Published: 09/02/2020 Desc: Rebound Tonometer
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html