Anhui Deepblue Medical Technology Co., Ltd.
Manufacturer and brand owner in Hefei, Anhui, China. 16 device types, 3 products catalogued, 2 clearances.
Anhui Deepblue Medical Technology Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Media, Coupling, Ultrasound, Test, Opiates, Over The Counter and 14 other device types. 3 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2023.
16device types registered with the FDA
3products catalogued under its own name
2510(k) clearances
Registration
| Registered name | ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3016447251 |
| FEI number | 3016447251 |
| DUNS | 546403492 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 安徽深蓝医疗科技股份有限公司 |
|---|---|
| Unified social credit code | 913401005501903714 |
| Source | NMPA UDI database |
Location
| City | Hefei |
|---|---|
| Province | Anhui |
| Address | No. 777 Jimingshan Road |
| Postal code | 230088 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Kit, Test, Pregnancy, Hcg, Over The Counter | Class 2 | HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), Ovulation Test + Pregnancy Test Combo | 2024 | 30 |
| Media, Coupling, Ultrasound | Class 2 | Sterile and Non-Sterile Ultrasonic Coupling Agent | 2024 | 8 |
| Test, Amphetamine, Over The Counter | Class 2 | Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup | 2025 | 16 |
| Test, Barbiturate, Over The Counter | Class 2 | Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup | 2025 | 16 |
| Test, Benzodiazepine, Over The Counter | Class 2 | Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup | 2025 | 16 |
| Test, Cannabinoid, Over The Counter | Class 2 | Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup | 2025 | 16 |
| Test, Cocaine And Cocaine Metabolites, Over The Counter | Class 2 | Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup | 2025 | 16 |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | Class 1 | Follicle-Stimulating Hormone (FSH) Menopause test | 2023 | 30 |
| Test, Luteinizing Hormone (Lh), Over The Counter | Class 1 | Luteinizing Hormone (LH) Ovulation test | 2023 | 38 |
| Test, Methadone, Over The Counter | Class 2 | Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup | 2025 | 17 |
| Test, Methamphetamine, Over The Counter | Class 2 | Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup | 2025 | 16 |
| Test, Opiates, Over The Counter | Class 2 | Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup | 2025 | 18 |
| Test, Phencyclidine (Pcp), Over The Counter | Class U | Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup | 2025 | 12 |
| Test, Propoxyphene, Over The Counter | Class 2 | Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup | 2025 | 16 |
| Test, Tricyclic Antidepressants, Over The Counter | Class 2 | Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup | 2025 | 16 |
| Visual, Pregnancy Hcg, Prescription Use | Class 2 | HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), Ovulation Test + Pregnancy Test Combo | 2024 | 16 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Follicle-Stimulating Hormone (FSH) Menopause test | NGA | 2 |
| Luteinizing Hormone (LH) Ovulation test | NGE | 2 |
| HCG Home Use Pregnancy Test Midstream (Colloidal Gold) | JHI | 1 |
Clearances
2 clearances name Anhui Deepblue Medical Technology Co., Ltd. as applicant. 1 is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K240242 | 2024-10-11 | LCX | Traditional | This company |
| K242167 | 2024-09-19 | MUI | Traditional | This company |
| K250803 | 2025-04-15 | NGL | Traditional | Anhui Deepblue Medical Technological Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2010 |
|---|---|
| Employees | 200 |
| Factory area | 10000 |
| Main products | Infectious disease tests, Respiratory disease tests, Fertility tests, Drug abuse screening tests, Tumor marker and inflammation tests |
| Certifications | MDSAP, ISO 13485, CE0123, CE3018, CE1434, IVDR |
| Export markets | Germany, Italy, Portugal, Mexico, Brazil, Peru, Indonesia, Bangladesh, UAE, Tanzania, Turkey, UK, USA |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.