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Sign in to claim this brandNantong Egens Biotechnology Co., Ltd.
US
Last updated May 23, 2026
What Nantong Egens Biotechnology Co., Ltd. makes
Nantong Egens Biotechnology Co., Ltd. manufactures midstream urine pregnancy test devices, including the EGENS Pregnancy Test Midstream I and EGENS Pregnancy Test Midstream II. These products are designed for home use to detect human chorionic gonadotropin (hCG) in urine, confirming pregnancy results.
The company’s pregnancy test devices are classified as Class II under regulatory frameworks and have been listed via the FDA’s 510(k) pathway. These products are intended for use in the United States, where they must comply with applicable medical device regulations.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Nantong Egens Biotechnology Co., Ltd. manufacture?
Nantong Egens Biotechnology Co., Ltd. specializes in midstream urine pregnancy test devices, specifically the EGENS Pregnancy Test Midstream I and EGENS Pregnancy Test Midstream II. These devices are designed for home use to detect the presence of human chorionic gonadotropin (hCG) in urine, helping users confirm pregnancy results.
Where is Nantong Egens Biotechnology Co., Ltd. based, and where are their devices intended for use?
Nantong Egens Biotechnology Co., Ltd. is based in the United States. Their pregnancy test devices are intended for use in the US market, where they must comply with applicable medical device regulations to ensure safety and performance.
How are Nantong Egens Biotechnology Co., Ltd.’s pregnancy test devices classified under regulatory frameworks?
Nantong Egens Biotechnology Co., Ltd.’s pregnancy test devices are classified as Class II medical devices. This classification is determined by regulatory authorities based on the risk associated with the device’s intended use and design. Class II devices typically require special controls in addition to general controls to ensure their safety and effectiveness.
Which regulatory registries or pathways have Nantong Egens Biotechnology Co., Ltd.’s devices been listed under?
Nantong Egens Biotechnology Co., Ltd.’s pregnancy test devices have been listed via the FDA’s 510(k) pathway. The 510(k) process is used to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, ensuring compliance with regulatory requirements before commercial distribution.
AI-generated from registry data and not verified by a human reviewer.
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- US
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Catalogue (44)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Egens | LH-S | FDA UDI | Class I | Active |
| One + Step | HCG-U11 | FDA UDI | Class II | Active |
| Rite Aid | LH-M01 | FDA UDI | Class I | Active |
| Rite Aid | HCG-M01 | FDA UDI | Class II | Active |
| Sure-Aid | HCG-M01 | FDA UDI | Class II | Active |
| Egens | HCG-U35H | FDA UDI | Class II | Active |
| Rite Aid | HCG-M02 | FDA UDI | Class II | Active |
| Egens | THC-U23 | FDA UDI | Class II | Active |
| Smilecare | HCG-S3 | FDA UDI | Class II | Active |
| Good Neighbor | LH-M01 | FDA UDI | Class I | Active |
| sunmark | HCG-M02 | FDA UDI | Class II | Active |
| Paraid | HCG-U24H | FDA UDI | Class II | Active |
| Egens | HCG-U35H | FDA UDI | Class II | Active |
| Signal | HCG-U24H | FDA UDI | Class II | Active |
| Egens | HCG-U11H | FDA UDI | Class II | Active |
| Foster & Thrive | HCG-M01 | FDA UDI | Class II | Active |
| Rite Aid | HCG-M01 | FDA UDI | Class II | Active |
| Foster & Thrive | HCG-M02 | FDA UDI | Class II | Active |
| Paraid | HCG-M04 | FDA UDI | Class II | Active |
| sunmark | HCG-M01 | FDA UDI | Class II | Active |
| Good Neighbor | HCG-M01 | FDA UDI | Class II | Active |
| Egens | LH-U24H | FDA UDI | Class I | Active |
| One + Step | HCG-U11 | FDA UDI | Class II | Active |
| Rite Aid | HCG-M02 | FDA UDI | Class II | Active |
| One + Step | HCG-U11 | FDA UDI | Class II | Active |
| Good Neighbor | HCG-M02 | FDA UDI | Class II | Active |
| Good Neighbor | HCG-M02 | FDA UDI | Class II | Active |
| Smilecare | LH -S50 | FDA UDI | Class I | Active |
| Rite Aid | HCG-M02 | FDA UDI | Class II | Active |
| Good Neighbor | HCG-M01 | FDA UDI | Class II | Active |
| Signal | THC-U24 | FDA UDI | Class II | Active |
| Rite Aid | HCG-M02 | FDA UDI | Class II | Active |
| Egens | LH-C | FDA UDI | Class I | Active |
| Egens | HCG-U11H | FDA UDI | Class II | Active |
| One + Step | HCG-U35 | FDA UDI | Class II | Active |
| One + Step | HCG-U23 | FDA UDI | Class II | Active |
| Sure-Aid | HCG-C01 | FDA UDI | Class II | Active |
| Egens | LH-M | FDA UDI | Class I | Active |
| Egens | HCG-U24H | FDA UDI | Class II | Active |
| Zioxx | LH -S50 | FDA UDI | Class I | Active |
| Egens One Step Hcg Urine Pregnancy Test Kit(s) (strip, Cassette, Midstream I And Midstream Ii) | K123050 | FDA 510(k) | Class II | Active |
| EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test Cassette Marijuana | K152643 | FDA 510(k) | Class II | Active |
| EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine - Methamphetamine | K151557 | FDA 510(k) | Class II | Active |
| EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II | K232864 | FDA 510(k) | Class II | Active |
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