Minlong Pharmaceutical Biotechnology (Shenzhen) Co., Ltd.
Registered establishment in Shenzhen, Guangdong, China. 21 device types.
Minlong Pharmaceutical Biotechnology (Shenzhen) Co., Ltd. is a repacker / relabeller holding a current FDA establishment registration. The registration covers Bandage, Elastic, Non-Surgical Gown and 19 other device types. Its earliest product listing with the FDA dates from 2024.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3031590640 |
| FEI number | 3031590640 |
| Establishment type | Repacker / relabeller, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 闽龙医药生物（深圳）股份有限公司 |
|---|---|
| Source | provincial manufacturer licence lists |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | Building 302, Kampar Chuang Industrial Park, Building 9A, Xinsha wuxiang |
| Postal code | 518118 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | Medical isolation mask/Disposable PE Gloves | 2024 | 439 |
| Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | Class 1 | Antigen,respiratory Syncytial Virus | 2024 | 4 |
| Antigens, Cf (Including Cf Control), Adenovirus 1-33 | Class 1 | denovirus antigen rapid detection kit | 2024 | 1 |
| Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4 | Class 1 | Anti-Parainfluenza Viruses test kit | 2024 | 2 |
| Antigens, Cf, All, Mycoplasma Spp. | Class 1 | Mycoplasma pneumonia AntigenRapid Test Cassette COVID-19 antigen detection kit | 2024 | 1 |
| Antisera, Hai, Influenza Virus A, B, C | Class 1 | RM Flu A&B/MP Antigen detection test kit(3in1) | 2024 | 1 |
| Applicator, Absorbent Tipped, Sterile | Class 1 | Disposable sampling swab | 2024 | 100 |
| Bag, Drainage, With Adhesive, Ostomy | Class 1 | Drainaqe bac | 2024 | 49 |
| Bandage, Elastic | Class 1 | Medical bandages,Protective bandage | 2024 | 280 |
| Container, Specimen Mailer And Storage, Non-Sterile | Class 1 | Disposable virus sampling tube | 2024 | 51 |
| Fentanyl And Other Opioid Protection Glove | Class 1 | Disposable Nitrile Examination Gloves, Disposable Vinyl/Nitrile Blend Gloves | 2026 | 29 |
| First Aid Kit Without Drug | Class 1 | First aid kit | 2024 | 132 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | Negative pressure drainage sponge block | 2026 | 266 |
| Kit, Serological, Negative Control | Class 1 | Syphilis Rapid Test Strip (Serum/Plasma/WholeBlood, HCVTest Strip ( Serum/Plasma/WVholeBlood) | 2024 | 1 |
| Kit, Serological, Positive Control | Class 1 | BsAg Test Serip( Serum/Plasma/WholeBlood), HIV 1/2/0 Test Strip (Serum/Plasma/WholeBlood) | 2024 | 1 |
| Medical Glove, Specialty | Class 1 | Disposable Nitrile Examination Gloves, Disposable Vinyl/Nitrile Blend Gloves | 2026 | 48 |
| Medical Gloves With Chemotherapy Labeling Claims – Test For Use With Chemotherapy Drugs | Class 1 | Disposable Nitrile Examination Gloves, Disposable Vinyl/Nitrile Blend Gloves | 2026 | 32 |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | Class 1 | Disposable atomizer (handheld) | 2024 | 57 |
| Non-Surgical Gown | Class 1 | Disposable PE Gloves | 2024 | 318 |
| Personal Protection Kit | Class 1 | Disposable nitrile glovcs;Disposablelatex gloves; Disposable PVC gloves; Disposable mixed Ding gloves | 2024 | 8 |
| Polymer Patient Examination Glove | Class 1 | Disposable Nitrile Examination Gloves, Disposable Vinyl/Nitrile Blend Gloves | 2026 | 83 |
Clearances
No clearance names Minlong Pharmaceutical Biotechnology (Shenzhen) Co., Ltd. as applicant. One 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 |
|---|---|---|---|---|
| K222714 | 2022-10-07 | LZA | Special | Guangdong Kingfa Medical SCI.&Tech. Co., Ltd. |
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.