Shenzhen Industry · 89-08 · CHINA
For Shenzhen Industry, 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 Fude Bldg , 839 Rm; Fuyongzhen Longgang District , Shenzhen, Guangdong CHINA, verified against its source on 2026-09-30.
- Firm
- Shenzhen Industry 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
- Fude Bldg , 839 Rm; Fuyongzhen Longgang District , Shenzhen, Guangdong 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
Shenzhen Industry Date Published : 07/20/2012 Fude Bldg , 839 Rm; Fuyongzhen Longgang District , Shenzhen, Guangdong 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