Reference Source

GUANGZHOU EKAI ELECTRONIC TECHNO · 89-08 · CHINA

For GUANGZHOU EKAI ELECTRONIC TECHNO · 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 Hydra Roller | Microneedle | Hydra Pen | Meso Pen | Microneedle Pen | Hydra Needle | Derma Pen | Hydra Needle | Derma Pen | Meso Pen | Microneedle Pen | Hydra Roller | Hydra Pen | Microneedle | Hydra Roller | Meso Pen | Hydra Needle | Derma Pen | Microneedle | Hydra Pen | Microneedle Pen | Derma Pen | Microneedle | Meso Pen | Microneedle Pen | Hydra Pen | Hydra Needle | Hydra Roller | Microneedle | Meso Pen | Hydra Roller | Derma Pen | Microneedle Pen | Hydra Needle | Hydra Pen | Microneedle Pen | Meso Pen | Hydra Roller | Hydra Pen | Derma Pen | Hydra Needle | Microneedle; product code is 79 Q - - AI Powered microneedle device | 79 Q - - AI Powered microneedle device | 79 Q - - AI Powered microneedle device | 79 Q - - AI Powered microneedle device | 79 Q - - AI Powered microneedle device | 79 Q - - AI Powered microneedle device | 79 Q - - AI Powered microneedle device | 80 K - - YZ Syringe, Irrigating | 80 K - - YZ Syringe, Irrigating | 80 K - - YZ Syringe, Irrigating | 80 K - - YZ Syringe, Irrigating | 80 K - - YZ Syringe, Irrigating | 80 K - - YZ Syringe, Irrigating | 80 K - - YZ Syringe, Irrigating | 80 M - - QX Needle, Acupuncture, Single Use | 80 M - - QX Needle, Acupuncture, Single Use | 80 M - - QX Needle, Acupuncture, Single Use | 80 M - - QX Needle, Acupuncture, Single Use | 80 M - - QX Needle, Acupuncture, Single Use | 80 M - - QX Needle, Acupuncture, Single Use | 80 M - - QX Needle, Acupuncture, Single Use | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric | 89 K - - NM Device, Pressure Applying | 89 K - - NM Device, Pressure Applying | 89 K - - NM Device, Pressure Applying | 89 K - - NM Device, Pressure Applying | 89 K - - NM Device, Pressure Applying | 89 K - - NM Device, Pressure Applying | 89 K - - NM Device, Pressure Applying | 89 L - - YG Massager, Therapeutic, Manual | 89 L - - YG Massager, Therapeutic, Manual | 89 L - - YG Massager, Therapeutic, Manual | 89 L - - YG Massager, Therapeutic, Manual | 89 L - - YG Massager, Therapeutic, Manual | 89 L - - YG Massager, Therapeutic, Manual | 89 L - - YG Massager, Therapeutic, Manual; date published is 11/30/2022; address is Building A F/3 , No. 81 Zijing Street , Guangzhou, Guangdong CHINA, verified against its source on 2026-09-16.

Firm
GUANGZHOU EKAI ELECTRONIC TECHNO 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
Building A F/3 , No. 81 Zijing Street , Guangzhou, Guangdong CHINA verified
Date published
11/30/2022 verified
Product code
79 Q - - AI Powered microneedle device | 79 Q - - AI Powered microneedle device | 79 Q - - AI Powered microneedle device | 79 Q - - AI Powered microneedle device | 79 Q - - AI Powered microneedle device | 79 Q - - AI Powered microneedle device | 79 Q - - AI Powered microneedle device | 80 K - - YZ Syringe, Irrigating | 80 K - - YZ Syringe, Irrigating | 80 K - - YZ Syringe, Irrigating | 80 K - - YZ Syringe, Irrigating | 80 K - - YZ Syringe, Irrigating | 80 K - - YZ Syringe, Irrigating | 80 K - - YZ Syringe, Irrigating | 80 M - - QX Needle, Acupuncture, Single Use | 80 M - - QX Needle, Acupuncture, Single Use | 80 M - - QX Needle, Acupuncture, Single Use | 80 M - - QX Needle, Acupuncture, Single Use | 80 M - - QX Needle, Acupuncture, Single Use | 80 M - - QX Needle, Acupuncture, Single Use | 80 M - - QX Needle, Acupuncture, Single Use | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric | 89 K - - NM Device, Pressure Applying | 89 K - - NM Device, Pressure Applying | 89 K - - NM Device, Pressure Applying | 89 K - - NM Device, Pressure Applying | 89 K - - NM Device, Pressure Applying | 89 K - - NM Device, Pressure Applying | 89 K - - NM Device, Pressure Applying | 89 L - - YG Massager, Therapeutic, Manual | 89 L - - YG Massager, Therapeutic, Manual | 89 L - - YG Massager, Therapeutic, Manual | 89 L - - YG Massager, Therapeutic, Manual | 89 L - - YG Massager, Therapeutic, Manual | 89 L - - YG Massager, Therapeutic, Manual | 89 L - - YG Massager, Therapeutic, Manual each item verified
Product
Hydra Roller | Microneedle | Hydra Pen | Meso Pen | Microneedle Pen | Hydra Needle | Derma Pen | Hydra Needle | Derma Pen | Meso Pen | Microneedle Pen | Hydra Roller | Hydra Pen | Microneedle | Hydra Roller | Meso Pen | Hydra Needle | Derma Pen | Microneedle | Hydra Pen | Microneedle Pen | Derma Pen | Microneedle | Meso Pen | Microneedle Pen | Hydra Pen | Hydra Needle | Hydra Roller | Microneedle | Meso Pen | Hydra Roller | Derma Pen | Microneedle Pen | Hydra Needle | Hydra Pen | Microneedle Pen | Meso Pen | Hydra Roller | Hydra Pen | Derma Pen | Hydra Needle | Microneedle 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

GUANGZHOU EKAI ELECTRONIC TECHNO Date Published : 11/30/2022 Building A F/3 , No. 81 Zijing Street , Guangzhou, Guangdong CHINA 79 Q - - AI Powered microneedle device Date Published: 11/30/2022 Desc: Hydra Roller 79 Q - - AI Powered microneedle device Date Published: 11/30/2022 Desc: Microneedle 79 Q - - AI Powered microneedle device Date Published: 11/30/2022 Desc: Hydra Pen 79 Q - - AI Powered microneedle device Date Published: 11/30/2022 Desc: Meso Pen 79 Q - - AI Powered microneedle device Date Published: 11/30/2022 Desc: Microneedle Pen 79 Q - - AI Powered microneedle device Date Published: 11/30/2022 Desc: Hydra Needle 79 Q - - AI Powered microneedle device Date Published: 11/30/2022 Desc: Derma Pen 80 K - - YZ Syringe, Irrigating Date Published: 11/30/2022 Desc: Hydra Needle 80 K - - YZ Syringe, Irrigating Date Published: 11/30/2022 Desc: Derma Pen 80 K - - YZ Syringe, Irrigating Date Published: 11/30/2022 Desc: Meso Pen 80 K - - YZ Syringe, Irrigating Date Published: 11/30/2022 Desc: Microneedle Pen 80 K - - YZ Syringe, Irrigating Date Published: 11/30/2022 Desc: Hydra Roller 80 K - - YZ Syringe, Irrigating Date Published: 11/30/2022 Desc: Hydra Pen 80 K - - YZ Syringe, Irrigating Date Published: 11/30/2022 Desc: Microneedle 80 M - - QX Needle, Acupuncture, Single Use Date Published: 11/30/2022 Desc: Hydra Roller 80 M - - QX Needle, Acupuncture, Single Use Date Published: 11/30/2022 Desc: Meso Pen 80 M - - QX Needle, Acupuncture, Single Use Date Published: 11/30/2022 Desc: Hydra Needle 80 M - - QX Needle, Acupuncture, Single Use Date Published: 11/30/2022 Desc: Derma Pen 80 M - - QX Needle, Acupuncture, Single Use Date Published: 11/30/2022 Desc: Microneedle 80 M - - QX Needle, Acupuncture, Single Use Date Published: 11/30/2022 Desc: Hydra Pen 80 M - - QX Needle, Acupuncture, Single Use Date Published: 11/30/2022 Desc: Microneedle Pen 89 I - - SA Massager, Therapeutic, Electric Date Published: 11/30/2022 Desc: Derma Pen 89 I - - SA Massager, Therapeutic, Electric Date Published: 11/30/2022 Desc: Microneedle 89 I - - SA Massager, Therapeutic, Electric Date Published: 11/30/2022 Desc: Meso Pen 89 I - - SA Massager, Therapeutic, Electric Date Published: 11/30/2022 Desc: Microneedle Pen 89 I - - SA Massager, Therapeutic, Electric Date Published: 11/30/2022 Desc: Hydra Pen 89 I - - SA Massager, Therapeutic, Electric Date Published: 11/30/2022 Desc: Hydra Needle 89 I - - SA Massager, Therapeutic, Electric Date Published: 11/30/2022 Desc: Hydra Roller 89 K - - NM Device, Pressure Applying Date Published: 11/30/2022 Desc: Microneedle 89 K - - NM Device, Pressure Applying Date Published: 11/30/2022 Desc: Meso Pen 89 K - - NM Device, Pressure Applying Date Published: 11/30/2022 Desc: Hydra Roller 89 K - - NM Device, Pressure Applying Date Published: 11/30/2022 Desc: Derma Pen 89 K - - NM Device, Pressure Applying Date Published: 12/13/2022 Desc: Microneedle Pen 89 K - - NM Device, Pressure Applying Date Published: 11/30/2022 Desc: Hydra Needle 89 K - - NM Device, Pressure Applying Date Published: 11/30/2022 Desc: Hydra Pen 89 L - - YG Massager, Therapeutic, Manual Date Published: 11/30/2022 Desc: Microneedle Pen 89 L - - YG Massager, Therapeutic, Manual Date Published: 11/30/2022 Desc: Meso Pen 89 L - - YG Massager, Therapeutic, Manual Date Published: 11/30/2022 Desc: Hydra Roller 89 L - - YG Massager, Therapeutic, Manual Date Published: 11/30/2022 Desc: Hydra Pen 89 L - - YG Massager, Therapeutic, Manual Date Published: 11/30/2022 Desc: Derma Pen 89 L - - YG Massager, Therapeutic, Manual Date Published: 11/30/2022 Desc: Hydra Needle 89 L - - YG Massager, Therapeutic, Manual Date Published: 11/30/2022 Desc: Microneedle

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

Source

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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