FDA Registration
Active
🇨🇳 China
Minlong Pharmaceutical Biotechnology (Shenzhen) Co., Ltd.
Reg #: 3031590640
·
FEI: 3031590640
·
Expires 2026
Products
20
Proprietary Names
20
Establishment Types
3
Classifications
20
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Registration Details
- Registration Name
- Minlong Pharmaceutical Biotechnology (Shenzhen) Co., Ltd.
- Registration Number
- 3031590640
- FEI Number
- 3031590640
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Building 302, Kampar Chuang Industrial Park, Building 9A, Xinsha wuxiang, biling community, Biling Street, Pingshan District
- City
- shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K222714
Owner / Operator
- Firm Name
- Minlong Pharmaceutical Biotechnology (Shenzhen) Co., Ltd
- Operator Number
- 10090805
- Address
- Room 301, Building A, Jinbaochuang Industrial Park, No. 9, Xinsha 5th Lane, Biling Community, Biling Street,, Pingshan District,
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518000
- Country
- CN
- Correspondent
- Wenlong Zhang
US Agent
- Business Name
- Jiamei consulting inc
- Contact Name
- Peter Yang
- Address
- 418 Broadway Ste R
- City
- Albany
- State
- NY
- ZIP
- 12207
- Country
- US
- [email protected]
- Phone
- 310 2168437
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4 | GQS | Class 1 | Microbiology | No | 2024-05-16 |
| Antisera, Hai, Influenza Virus A, B, C | GNS | Class 1 | Microbiology | No | 2024-05-16 |
| Bag, Drainage, With Adhesive, Ostomy | FON | Class 1 | Gastroenterology, Urology | No | 2024-05-16 |
| Kit, Serological, Negative Control | MJY | Class 1 | Clinical Chemistry | No | 2024-08-16 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2026-02-22 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2026-02-22 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2026-02-22 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2026-02-22 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2024-05-16 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2024-05-16 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2024-05-16 |
| Antigens, Cf, All, Mycoplasma Spp. | GSB | Class 1 | Microbiology | No | 2024-05-16 |
| Kit, Serological, Positive Control | MJX | Class 1 | Clinical Chemistry | No | 2024-08-16 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2024-05-16 |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | Class 1 | Pathology | No | 2024-05-16 |
| Antigens, Cf (Including Cf Control), Adenovirus 1-33 | GOD | Class 1 | Microbiology | No | 2024-05-16 |
| First Aid Kit Without Drug | OHO | Class 1 | General, Plastic Surgery | No | 2024-07-30 |
| Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | GQG | Class 1 | Microbiology | No | 2024-05-16 |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | Class 1 | Anesthesiology | No | 2024-05-16 |
| Personal Protection Kit | PXC | Class 1 | General Hospital | No | 2024-08-16 |
Proprietary Names
Anti-Parainfluenza Viruses test kit
RM Flu A&B/MP Antigen detection test kit(3in1)
Drainaqe bac
HCVTest Strip ( Serum/Plasma/WVholeBlood)
Syphilis Rapid Test Strip (Serum/Plasma/WholeBlood
DISPOSABLE NITRILE EXAMINATION GLOVES
DISPOSABLE VINYL/NITRILE BLEND GLOVES
Disposable PE Gloves
Disposable sampling swab
Medical isolation mask/Disposable PE Gloves
Mycoplasma pneumonia AntigenRapid Test Cassette COVID-19 antigen detection kit
HIV 1/2/0 Test Strip (Serum/Plasma/WholeBlood)
BsAg Test Serip( Serum/Plasma/WholeBlood)
Medical bandages,Protective bandage
Disposable virus sampling tube
denovirus antigen rapid detection kit
First aid kit
ANTIGEN ,RESPIRATORY SYNCYTIAL VIRUS
Disposable atomizer (handheld)
Disposable nitrile glovcs;Disposablelatex gloves; Disposable PVC gloves; Disposable mixed Ding gloves
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Export Device to the United States But Perform No Other Operation on Device