FDA Registration
Active
🇨🇳 China
VIVACHEK BIOTECH (HANGZHOU) CO., LTD
Reg #: 3013223546
·
FEI: 3013223546
·
Expires 2026
Products
21
Proprietary Names
8
Establishment Types
3
Classifications
21
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Registration Details
- Registration Name
- VIVACHEK BIOTECH (HANGZHOU) CO., LTD
- Registration Number
- 3013223546
- FEI Number
- 3013223546
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.17 Wuzhou Road, Donghu Street, Linping District, Hangzhou, 311100, Building 2 and Building 3, No.17 Jianxing Road, Taozhu Street, Zhuji, 311800
- City
- Hangzhou, Zhuji Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K173140
Owner / Operator
- Firm Name
- VivaChek Biotech (Hangzhou) Co., Ltd
- Operator Number
- 10055002
- Address
- No.17 Wuzhou Road, Donghu Street, Linping District,
- City
- Hangzhou
- State
- Zhejiang
- Postal Code
- 311100
- Country
- CN
- Correspondent
- Mark Qian
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2019-02-19 |
| Test, Tricyclic Antidepressants, Over The Counter | QAW | Class 2 | Clinical Toxicology | No | 2022-12-04 |
| Test, Cannabinoid, Over The Counter | NFW | Class 2 | Clinical Toxicology | No | 2022-12-04 |
| Test, Methadone, Over The Counter | PTG | Class 2 | Clinical Toxicology | No | 2022-12-04 |
| Test, Cocaine And Cocaine Metabolites, Over The Counter | NFY | Class 2 | Clinical Toxicology | No | 2022-12-04 |
| Test, Benzodiazepine, Over The Counter | NFV | Class 2 | Clinical Toxicology | No | 2022-12-04 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2022-12-04 |
| Test, Amphetamine, Over The Counter | NFT | Class 2 | Clinical Toxicology | No | 2022-12-04 |
| Test, Propoxyphene, Over The Counter | QBF | Class 2 | Clinical Toxicology | No | 2022-12-04 |
| Test, Barbiturate, Over The Counter | PTH | Class 2 | Clinical Toxicology | No | 2022-12-04 |
| Test, Opiates, Over The Counter | NGL | Class 2 | Clinical Toxicology | No | 2022-12-04 |
| Test, Methamphetamine, Over The Counter | NGG | Class 2 | Clinical Toxicology | No | 2022-12-04 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2020-06-27 |
| Fluorometer, For Clinical Use | KHO | Class 1 | Clinical Chemistry | No | 2025-03-06 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2017-05-23 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2017-05-23 |
| Test, Phencyclidine (Pcp), Over The Counter | NGM | Class U | Unknown | No | 2025-12-01 |
| Device, Cystometric, Hydraulic | FEN | Class 2 | Gastroenterology, Urology | No | 2024-03-18 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2024-06-25 |
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | Class 2 | General, Plastic Surgery | No | 2022-11-17 |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | Class 2 | General, Plastic Surgery | No | 2022-11-17 |
Proprietary Names
VivaGuard Ino Sound Simple Blood Glucose Monitoring System
VivaGuard Ino BLOOD GLUCOSE TEST STRIPS
VivaGuard Multi-Drug Urine Test Cup
VivaGuard Multi-Drug Urine Test Cup Rx
VivaDiag Marijuana (THC) Rapid Test
VivaDiag Fentanyl Test Kit (FIA)
VivaDiag POCT Multifunction Meter
VivaGuard Fad Blood Glucose Monitoring System
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device