Reference Source

GUANGZHOU EKAI ELECTRONIC TECHNO · 89-08 · CHINA

For GUANGZHOU EKAI ELECTRONIC TECHNO, import alert is 89-08; country is CHINA; 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 Hydra Needle | Meso Pen | Hydra Pen | Microneedle Pen | Derma Pen | Microneedle | Hydra Roller | Hydra Needle | Meso Pen | Hydra Pen | Microneedle Pen | Derma Pen | Microneedle | Hydra Roller | Hydra Needle | Meso Pen | Hydra Pen | Microneedle Pen | Derma Pen | Microneedle | Hydra Roller | Hydra Needle | Meso Pen | Hydra Pen | Microneedle Pen | Derma Pen | Microneedle | Hydra Roller | Hydra Needle | Microneedle Pen | Meso Pen | Hydra Pen | Derma Pen | Microneedle | Hydra Roller | Hydra Needle | Hydra Roller | Microneedle | Derma Pen | Microneedle Pen | Hydra Pen | Meso Pen; 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 2026-09-30.

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 Needle | Meso Pen | Hydra Pen | Microneedle Pen | Derma Pen | Microneedle | Hydra Roller | Hydra Needle | Meso Pen | Hydra Pen | Microneedle Pen | Derma Pen | Microneedle | Hydra Roller | Hydra Needle | Meso Pen | Hydra Pen | Microneedle Pen | Derma Pen | Microneedle | Hydra Roller | Hydra Needle | Meso Pen | Hydra Pen | Microneedle Pen | Derma Pen | Microneedle | Hydra Roller | Hydra Needle | Microneedle Pen | Meso Pen | Hydra Pen | Derma Pen | Microneedle | Hydra Roller | Hydra Needle | Hydra Roller | Microneedle | Derma Pen | Microneedle Pen | Hydra Pen | Meso Pen 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

— accessdata.fda.gov, retrieved 2026-09-22

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 and Product

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: Meso Pen 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: Microneedle Pen 79 Q - - AI Powered microneedle device Date Published: 11/30/2022 Desc: Derma Pen 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 Roller 80 K - - YZ Syringe, Irrigating Date Published: 11/30/2022 Desc: Hydra Needle 80 K - - YZ Syringe, Irrigating Date Published: 11/30/2022 Desc: Meso Pen 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 Pen 80 K - - YZ Syringe, Irrigating Date Published: 11/30/2022 Desc: Derma Pen 80 K - - YZ Syringe, Irrigating Date Published: 11/30/2022 Desc: Microneedle 80 K - - YZ Syringe, Irrigating Date Published: 11/30/2022 Desc: Hydra Roller 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: Meso Pen 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 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 Roller 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: Meso 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: 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: Hydra Roller 89 K - - NM Device, Pressure Applying Date Published: 11/30/2022 Desc: Hydra Needle 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: Meso Pen 89 K - - NM Device, Pressure Applying Date Published: 11/30/2022 Desc: Hydra Pen 89 K - - NM Device, Pressure Applying Date Published: 11/30/2022 Desc: Derma Pen 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: Hydra Roller 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: Hydra Roller 89 L - - YG Massager, Therapeutic, Manual Date Published: 11/30/2022 Desc: Microneedle 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: Microneedle Pen 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: Meso Pen

— all from accessdata.fda.gov, retrieved 2026-09-22

Source

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