Shenzhen NEW Industries Biomedical Engineering Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 4 device types, 7 products catalogued, 5 clearances.
Shenzhen NEW Industries Biomedical Engineering Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers System, Test, Vitamin D, Reagent, Coronavirus Serological and 2 other device types. 6 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2020.
Registration
| Registered name | SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO.,LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3010610113 |
| FEI number | 3010610113 |
| DUNS | 421745241 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 深圳市新产业生物医学工程股份有限公司 |
|---|---|
| Unified social credit code | 914403001923998520 |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | No.23 Jinxiu East Road |
| Postal code | 518122 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | Class 1 | MAGLUMI X8 Fully-auto chemiluminescence immunoassay analyzer, MAGLUMI X10 Fully-auto chemiluminescence immunoassay analyzer, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer, MAGLUMI 25-OH Vitamin D | 2026 | 16 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Class 1 | SATLARS T8 Laboratory Automation System | 2026 | 72 |
| Reagent, Coronavirus Serological | Class N | MAGLUMI 2019-nCoV IgM, MAGLUMI 2019-nCoV IgG | 2020 | 12 |
| System, Test, Vitamin D | Class 2 | MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer, MAGLUMI 25-OH Vitamin D | 2026 | 1 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Maglumi 25-OH Vitamin D | MRG | 3 |
| Maglumi 2000 HCG/beta-HCG | DHA | 2 |
| Maglumi 2000 TSH | JLW | 2 |
| Maglumi 2000 25-OH Vitamin D | MRG | 2 |
| Maglumi X3 Fully-auto chemiluminescence immunoassay analyzer | JJE | 1 |
| Maglumi 2000 Immunoassay Analyzer | JJE | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K232587 | 2024-04-12 | MRG | Traditional | This company |
| K192547 | 2020-01-17 | DHA | Traditional | This company |
| K191499 | 2019-08-01 | MRG | Traditional | This company |
| K182423 | 2018-10-04 | CEC | Traditional | This company |
| K162698 | 2017-07-14 | JLW | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1995 |
|---|---|
| Employees | 2700 |
| Factory area | 55000 m² |
| Main products | CLIA immunoassay analyzers, Biochemistry analyzers, Molecular diagnostic analyzers, Coagulation analyzers, Lab automation systems |
| Certifications | ISO 9001, ISO 13485, CE, IVDR CE, RCPAQAP, IFCC |
| Export markets | Over 160 countries |
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.
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