Dolma Industry Limited · 89-08 · CHINA
For Dolma Industry Limited, 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 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 2026-09-30.
- 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
— 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, Product and FDA notes
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html