DONGYANG CITY YONOEL OUTDOOR PRODUCTS CO.,LTD
Official US Food and Drug Administration (FDA) Establishment Registration & Device/Facility Listing dossier for DONGYANG CITY YONOEL OUTDOOR PRODUCTS CO.,LTD (FEI 3021282544). Use this record to cross-check CBP ACE Affirmation of Compliance codes (`DEV` / `DFE` / `FEI`), verify the designated US Agent on file, and subscribe to automated Import Alert (DWPE) monitoring.
No. 52, hulian west road, Jiangbei Street
Dongyang Zhejiang, China (322100)
FEI Number: 3021282544
Registration No: 3021282544 • Status Code: 1 (Active)
Leeyeo Kee
Regrek LLC
Dover, DE (USA)
302-6089028
regrek.cs@hotmail.com
Registered FDA Product Codes, Device Classes & Commercial Names
Cross-check your commercial invoice product descriptions against these active FDA product code filings to prevent NO_510K or UNAPPROVED_NEW_DRUG port holds.
| Product Code | FDA Classification Name | Device Class | 21 CFR Regulation | 510(k) Exempt? |
|---|---|---|---|---|
| BYG | Mask, Oxygen | Class 1 | 21 CFR 868.5580 | Requires 510(k) / Check |
Download Normalized 5-Year Refusal, 483 & Recall Audit Workbook (.XLSX + CSV)
Includes all deduplicated overseas factory names, FEI/DUNS crosswalks, 5-year port refusal logs, plain-English statutory violation mappings, and FSVP supplier qualification templates ready for customs broker review.
- Full 5-year OASIS refusal history for DONGYANG CITY YONOEL OUTDOOR PRODUCTS CO.,LTD (FEI 3021282544) + category peers
- 21 CFR 1.505 Foreign Supplier Verification Program (FSVP) audit checklist tab
Instant Supplier Detention Webhook & Email Alert Monitor
Get an automated Slack/Webhook JSON payload and email alert within 15 minutes whenever FDA OASIS logs a new detention, Import Alert Red List addition, or Warning Letter for DONGYANG CITY YONOEL OUTDOOR PRODUCTS CO.,LTD (FEI 3021282544) before you wire your 70% balance payment.
Shipment Detained by FDA or Placed on Import Alert? Request Free 24h Detention Evaluation from Licensed US FDA Compliance Counsel
When FDA issues a Notice of FDA Action (Detention), importers typically have only 10 to 20 business days to file a Form FDA 766 relabeling application, submit an accredited private laboratory packet (PLAP), or petition for Import Alert Red List removal before CBP orders refusal and liquidated damages.
Other Verified FDA FEI Establishments in China
RUSUN MEDICAL CO., LTD
Yichun City Jiangxi, China • Reg Yr 2026
ZHONGSHAN A&E MACHINERY INDUSTRY CO., LTD
Zhongshan City Guangdong, China • Reg Yr 2027
JOYKEY INDUSTRIAL (PINGHU) LIMITED
Pinghu City Zhejiang, China • Reg Yr 2026
ZHEJIANG MEDIUNION HEALTHCARE GROUP CO.,LTD
Ningbo Zhejiang, China • Reg Yr 2026
Hangzhou AllTest Biotech Co.,Ltd
Hangzhou Zhejiang, China • Reg Yr 2027
SHANGHAI YUEYUESHU WOMEN PRODUCTS CO.,LTD.
Shanghai, China • Reg Yr 2026
Frequently Asked Questions: FEI 3021282544 (DONGYANG CITY YONOEL OUTDOOR PRODUCTS CO.,LTD)
What is the FDA FEI Number for DONGYANG CITY YONOEL OUTDOOR PRODUCTS CO.,LTD?
According to public US FDA Establishment Registration records, DONGYANG CITY YONOEL OUTDOOR PRODUCTS CO.,LTD (Dongyang Zhejiang, China) is assigned FDA Facility Establishment Identifier (FEI) 3021282544 (Registration No. 3021282544) with registration year 2026.
Who is the designated US Agent for FEI 3021282544 (DONGYANG CITY YONOEL OUTDOOR PRODUCTS CO.,LTD)?
The registered US Agent on file for FEI 3021282544 is Leeyeo Kee (Regrek LLC) located in Dover, DE. Importers should independently confirm active representation before filing CBP ACE entry.
Does an active FDA FEI registration guarantee that shipments from DONGYANG CITY YONOEL OUTDOOR PRODUCTS CO.,LTD will clear US Customs without detention?
No. An active FDA FEI number or establishment registration only confirms administrative listing in FDA FURLS. Shipments can still be detained at US ports under Detention Without Physical Examination (DWPE / Import Alerts) for labeling, 510(k), cGMP, or adulteration violations.