Azad International (HK) Ltd · 89-08 · HONG KONG SAR
For Azad International (HK) Ltd, import alert is 89-08; country is HONG KONG SAR; 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 Smart Swab | Smart Swab; product code is 76 M - - GE Hearing-Aid, Audiodontic | 77 J - - YG Curette, Ear | 77 J - - YT Pick, Microsurgical Ear; date published is 09/16/2009; address is Trw 1 Room 2103 , 33 Canton Road , Mong Kok, Kowloon HONG KONG SAR, verified against its source on 2026-09-30.
- Firm
- Azad International (HK) 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
- HONG KONG SAR verified
- Address
- Trw 1 Room 2103 , 33 Canton Road , Mong Kok, Kowloon HONG KONG SAR verified
- Date published
- 09/16/2009 verified
- Product code
- 76 M - - GE Hearing-Aid, Audiodontic | 77 J - - YG Curette, Ear | 77 J - - YT Pick, Microsurgical Ear each item verified
- Product
- Smart Swab | Smart Swab each item verified
- FDA notes
- WhisperXL mini-sound amplifier (behind the ear hearing aid) 12/21/1994 | Device Classification is unknown. There is no specific product code or regulation that applies to this device at this time. It is recommended that the firm contacts ODE to submit a 513(g) or a 510(k). | Device Classification is unknown. There is no specific product code or regulation that applies to this device at this time. It is recommended that the firm contacts ODE to submit a 513(g) or a 510(k). each item verified
What the source says
Azad International (HK) Ltd Date Published : 09/16/2009 Trw 1 Room 2103 , 33 Canton Road , Mong Kok, Kowloon HONG KONG SAR
— 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
76 M - - GE Hearing-Aid, Audiodontic Date Published: 09/16/2009 Notes: WhisperXL mini-sound amplifier (behind the ear hearing aid) 12/21/1994 77 J - - YG Curette, Ear Date Published: 02/10/2017 Desc: Smart Swab Notes: Device Classification is unknown. There is no specific product code or regulation that applies to this device at this time. It is recommended that the firm contacts ODE to submit a 513(g) or a 510(k). 77 J - - YT Pick, Microsurgical Ear Date Published: 02/10/2017 Desc: Smart Swab Notes: Device Classification is unknown. There is no specific product code or regulation that applies to this device at this time. It is recommended that the firm contacts ODE to submit a 513(g) or a 510(k).
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html