WUHAN GUANGDUN TECHNOLOGY CO LTD · 89-08 · CHINA
For WUHAN GUANGDUN TECHNOLOGY CO LTD · 89-08 · CHINA, import alert is 89-08; 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)"; country is CHINA; product is Medical Laser | Medical Laser; product code is 79 G - - EX Powered laser surgical instruments | 89 N - - HN Lamp, Non-Heating, for Adjunctive Use in Pain Therapy; date published is 08/04/2017; address is F 3 , 303 Optical Valley Avenue; 3f, No. 303 Optical Chip Center, Optical Avenue , Wuhan, Hubei CHINA, verified against its source on 2026-09-16.
- Firm
- WUHAN GUANGDUN TECHNOLOGY CO 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
- F 3 , 303 Optical Valley Avenue; 3f, No. 303 Optical Chip Center, Optical Avenue , Wuhan, Hubei CHINA verified
- Date published
- 08/04/2017 verified
- Product code
- 79 G - - EX Powered laser surgical instruments | 89 N - - HN Lamp, Non-Heating, for Adjunctive Use in Pain Therapy each item verified
- Product
- Medical Laser | Medical Laser each item verified
- FDA notes
- Class II | Class II each item verified
What the source says
WUHAN GUANGDUN TECHNOLOGY CO LTD Date Published : 08/04/2017 F 3 , 303 Optical Valley Avenue; 3f, No. 303 Optical Chip Center, Optical Avenue , Wuhan, Hubei CHINA 79 G - - EX Powered laser surgical instruments Date Published: 08/04/2017 Desc: Medical Laser Notes: Class II 89 N - - HN Lamp, Non-Heating, for Adjunctive Use in Pain Therapy Date Published: 08/04/2017 Desc: Medical Laser Notes: Class II
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.