# Dolma Industry Limited · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** No 1016 Shennan Road (E) Futian District , Room 406 Block A Chunhuiyuan , Shenzhen City, CHINA _(verified: appears in the quote below)_
- **Date published:** 07/20/2012 _(verified: appears in the quote below)_
- **Product code:** 74 D - - RW Adaptor, Lead Switching, Electrocardiograph | 86 N - - FH Digitizer, Images, Ophthalmic _(verified: each item appears in the quote below)_
- **Product:** Quantum Bio-Electric System (Bio-Quantum System Sistema Avanzado) | Iriscope (Iriscopio) _(verified: each item appears in the quote below)_
- **FDA notes:** class II | class II _(verified: each item appears in the quote below)_

## 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

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).