Dolma Industry Limited · 89-08 · CHINA
For Dolma Industry Limited · 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 Quantum Bio-Electric System (Bio-Quantum System Sistema Avanzado) | Iriscope (Iriscopio); product code is 74 D - - RW Adaptor, Lead Switching, Electrocardiograph | 86 N - - FH Digitizer, Images, Ophthalmic; date published is 07/20/2012; address is No 1016 Shennan Road (E) Futian District , Room 406 Block A Chunhuiyuan , Shenzhen City, CHINA, verified against its source on 2026-09-16.
- Firm
- Dolma Industry Limited 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
- No 1016 Shennan Road (E) Futian District , Room 406 Block A Chunhuiyuan , Shenzhen City, CHINA verified
- Date published
- 07/20/2012 verified
- Product code
- 74 D - - RW Adaptor, Lead Switching, Electrocardiograph | 86 N - - FH Digitizer, Images, Ophthalmic each item verified
- Product
- Quantum Bio-Electric System (Bio-Quantum System Sistema Avanzado) | Iriscope (Iriscopio) each item verified
- FDA notes
- class II | class II each item verified
What the source says
Dolma Industry Limited Date Published : 07/20/2012 No 1016 Shennan Road (E) Futian District , Room 406 Block A Chunhuiyuan , Shenzhen City, CHINA 74 D - - RW Adaptor, Lead Switching, Electrocardiograph Date Published: 07/20/2012 Desc: Quantum Bio-Electric System (Bio-Quantum System Sistema Avanzado) Notes: class II 86 N - - FH Digitizer, Images, Ophthalmic Date Published: 07/20/2012 Desc: Iriscope (Iriscopio) 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.