Reference Source

Creative Concepts Manufacturing Ltd · 89-08 · CHINA

For Creative Concepts Manufacturing Ltd · 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 UV Toothbrush Sanitizer | UV Toothbrush Sanitizer; product code is 76 N - - OB Unit,Ultraviolet Sanitation/Sterilization(For Toothbrushes),Non-Sterile | 80 K - - YZ Syringe, Irrigating; date published is 03/27/2015; address is A No. 50 Longquanbei Road , Ning Hai Dajiahe Town , Ningo City, CHINA, verified against its source on 2026-09-16.

Firm
Creative Concepts Manufacturing 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
CHINA verified
Address
A No. 50 Longquanbei Road , Ning Hai Dajiahe Town , Ningo City, CHINA verified
Date published
03/27/2015 verified
Product code
76 N - - OB Unit,Ultraviolet Sanitation/Sterilization(For Toothbrushes),Non-Sterile | 80 K - - YZ Syringe, Irrigating each item verified
Product
UV Toothbrush Sanitizer | UV Toothbrush Sanitizer each item verified
FDA notes
Class II | Class II each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Creative Concepts Manufacturing Ltd Date Published : 03/27/2015 A No. 50 Longquanbei Road , Ning Hai Dajiahe Town , Ningo City, CHINA 76 N - - OB Unit,Ultraviolet Sanitation/Sterilization(For Toothbrushes),Non-Sterile Date Published: 03/27/2015 Desc: UV Toothbrush Sanitizer Notes: Class II 80 K - - YZ Syringe, Irrigating Date Published: 03/27/2015 Desc: UV Toothbrush Sanitizer Notes: Class II

accessdata.fda.gov, retrieved 2026-09-15

The same source also states

Creative Concepts Manufacturing Ltd Date Published : 03/27/2015 Airport Rd , Ganzhen Fengjia Gongyequ Yinzhou District , Ningbo, Zhejiang CHINA 76 N - - OB Unit,Ultraviolet Sanitation/Sterilization(For Toothbrushes),Non-Sterile Date Published: 03/27/2015 Desc: UV Toothbrush Sanitizer Notes: Class II 80 K - - YZ Syringe, Irrigating Date Published: 03/27/2015 Desc: UV Toothbrush Sanitizer Notes: Class II

accessdata.fda.gov, retrieved 2026-09-15

Source

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