FDA Registration
Active
🇨🇳 China
ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO., LTD.
Reg #: 3016447251
·
FEI: 3016447251
·
Expires 2026
Products
16
Proprietary Names
8
Establishment Types
2
Classifications
16
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Registration Details
- Registration Name
- ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO., LTD.
- Registration Number
- 3016447251
- FEI Number
- 3016447251
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 777 Jimingshan Road, High-Tech Development Zone
- City
- Hefei Anhui
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K242167
Owner / Operator
- Firm Name
- ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO., LTD.
- Operator Number
- 10062344
- Address
- No. 777 Jimingshan Road, High-Tech Development Zone
- City
- Hefei
- State
- Anhui
- Postal Code
- 230088
- Country
- CN
- Correspondent
- Fengling Chen
US Agent
- Business Name
- Medlinkt Business Technology Inc
- Contact Name
- Gloria Wang
- Address
- 30 N Gould St Ste N Sheridan
- City
- Sheridan
- State
- WY
- ZIP
- 82801
- Country
- US
- [email protected]
- Phone
- 307 7769129
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Media, Coupling, Ultrasound | MUI | Class 2 | Radiology | No | 2024-10-28 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | Class 2 | Clinical Chemistry | No | 2024-10-28 |
| Visual, Pregnancy Hcg, Prescription Use | JHI | Class 2 | Clinical Chemistry | No | 2024-10-28 |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | NGA | Class 1 | Clinical Chemistry | No | 2023-12-14 |
| Test, Tricyclic Antidepressants, Over The Counter | QAW | Class 2 | Clinical Toxicology | No | 2025-04-22 |
| Test, Opiates, Over The Counter | NGL | Class 2 | Clinical Toxicology | No | 2025-04-22 |
| Test, Barbiturate, Over The Counter | PTH | Class 2 | Clinical Toxicology | No | 2025-04-22 |
| Test, Propoxyphene, Over The Counter | QBF | Class 2 | Clinical Toxicology | No | 2025-04-22 |
| Test, Benzodiazepine, Over The Counter | NFV | Class 2 | Clinical Toxicology | No | 2025-04-22 |
| Test, Phencyclidine (Pcp), Over The Counter | NGM | Class U | Unknown | No | 2025-04-22 |
| Test, Methadone, Over The Counter | PTG | Class 2 | Clinical Toxicology | No | 2025-04-22 |
| Test, Cocaine And Cocaine Metabolites, Over The Counter | NFY | Class 2 | Clinical Toxicology | No | 2025-04-22 |
| Test, Methamphetamine, Over The Counter | NGG | Class 2 | Clinical Toxicology | No | 2025-04-22 |
| Test, Cannabinoid, Over The Counter | NFW | Class 2 | Clinical Toxicology | No | 2025-04-22 |
| Test, Amphetamine, Over The Counter | NFT | Class 2 | Clinical Toxicology | No | 2025-04-22 |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | Class 1 | Clinical Chemistry | No | 2023-06-11 |
Proprietary Names
Sterile and Non-Sterile Ultrasonic Coupling Agent
HCG Home Use Pregnancy Test Strip (Colloidal Gold)
HCG Home Use Pregnancy Test Midstream (Colloidal Gold)
Ovulation Test + Pregnancy Test Combo
HCG Home Use Pregnancy Test Cassette (Colloidal Gold)
Follicle-Stimulating Hormone (FSH) Menopause test
Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup
Luteinizing Hormone (LH) Ovulation test
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)