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Sign in to claim this brandShenzhen Lifotronic Technology Co., Ltd.
China·CN-MF-000005654
Last updated September 18, 2026
About
Shenzhen Plenum Technology Co. Ltd. is a two-wheel-drive, specialized, high-tech, high-tech, state-owned, high-tech, open-market enterprise (Stocks: Pumen Technologies; Stock Code: 688389). The company is committed to the development, production, marketing and servicing of therapeutic and rehabilitative products, in vitro diagnostic equipment and accompanying reagents。
Translated from the manufacturer's own website. Source
What Shenzhen Lifotronic Technology Co., Ltd. makes
The company manufactures warming blankets for medical use, in vitro diagnostic (IVD) test kits including 25-hydroxy vitamin D assays, free testosterone (eCLIA) tests, and follicle-stimulating hormone (FSH) assays, as well as lateral flow immunoassay kits for triiodothyronine (T3). It also produces sleeves and eluent reagents for diagnostic applications.
The portfolio includes devices classified as Class A, B, C, I, II, IIa, IIb, and IVD General, with listings in the EU’s eudamed registry and FDA’s 510(k) database. The company is based in China.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Shenzhen Lifotronic Technology Co., Ltd. manufacture?
Shenzhen Lifotronic Technology Co., Ltd. primarily manufactures medical warming blankets, in vitro diagnostic (IVD) test kits, and related reagents. Their IVD portfolio includes assays for 25-hydroxy vitamin D, free testosterone (using eCLIA technology), follicle-stimulating hormone (FSH), and triiodothyronine (T3) via lateral flow immunoassays. Additionally, they produce sleeves and eluent reagents used in diagnostic applications.
Where is Shenzhen Lifotronic Technology Co., Ltd. based?
The company is headquartered in Shenzhen, China. This location reflects its focus on manufacturing and innovation in medical devices, including therapeutic, rehabilitative, and diagnostic products.
Which regulatory registries list devices manufactured by Shenzhen Lifotronic Technology Co., Ltd.?
Devices from Shenzhen Lifotronic Technology Co., Ltd. are listed in the EU’s eudamed registry and the FDA’s 510(k) database. These registries track devices that have undergone the relevant regulatory processes for market authorization in those regions.
How are the devices produced by Shenzhen Lifotronic Technology Co., Ltd. classified under medical device regulations?
The company’s devices span multiple regulatory classes depending on their risk level and intended use. Their portfolio includes Class A, B, and C (EU classification) as well as Class I, II, IIa, IIb (FDA classification), and IVD General (for in vitro diagnostics). Classification determines the regulatory scrutiny and authorization pathway required for market placement.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- China
- Address
- No. 8, Lifotronic Tower, Qiuzhi East Road, Shenzhen, China
- Website
- www.lifotronic.com/
- —
- —
- [email protected]
- Phone
- 0086-755-29060026
- PRRC Contact
- Minyi Pei
- EUDAMED SRN
- CN-MF-000005654
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (549)
Page 3 of 11| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Anti-TSHR (eCLIA) | 0320511303 | EUDAMED | IVD General | Active |
| Calcitonin (Electrochemiluminescence Immunoassay) | 693015 | EUDAMED | IVD General | Active |
| D-Dimer STAT (eCLIA) | 0320500301 | EUDAMED | IVD General | Active |
| MPO (eCLIA) | 0320509201 | EUDAMED | Class C | Active |
| Thyroid Peroxidase Antibody ( Electrochemiluminescence Immunoassay) | 690041 | EUDAMED | IVD General | Active |
| V80 eluent C | 0320200914 | EUDAMED | Class A | Active |
| HSV-I IgM (eCLIA) | 0320512602 | EUDAMED | IVD General | Active |
| Enhanced Washing Buffer | 0320507402 | EUDAMED | Class A | Active |
| Hb NEXT VT80 eluent B | 55044 | EUDAMED | Class A | Active |
| HSV-I IgG (eCLIA) | 0320512704 | EUDAMED | IVD General | Active |
| CA50 (eCLIA) | 0320509404 | EUDAMED | Class C | Active |
| Dengue NS1/IgG/IgM Test (GICA) | Dengue NS1/IgG/IgM Test (GICA) | EUDAMED | IVD General | Active |
| Procollagen III N-terminal peptide (PIIINP) eCLIA | 692020 | EUDAMED | IVD General | Active |
| Nucleic Acid Extraction Reagent (Swab) | 529004 | EUDAMED | Class A | Active |
| Progesterone (Electrochemiluminescence Immunoassay) | 697024 | EUDAMED | IVD General | Active |
| Luteinizing Hormone (Electrochemiluminescence Immunoassay) | 697016 | EUDAMED | Class B | Active |
| High-flow Humidification Device | NA | EUDAMED | Class IIa | Active |
| Thyroid stimulating hormone (Electrochemiluminescence immunoassay) | 690063 | EUDAMED | IVD General | Active |
| HbA1c Reagent Kits (HPLC) | 0320201001 | EUDAMED | Class A | Active |
| FDP (eCLIA) | 0320510204 | EUDAMED | IVD General | Active |
| Free Prostate Specific Antigen (eCLIA) | 0320501001 | EUDAMED | Class C | Active |
| Progesterone (Electrochemiluminescence Immunoassay) | 697023 | EUDAMED | IVD General | Active |
| Lipoprotein-Associated Phospholipase A2 (Electrochemiluminescence Immunoassay) | 691052 | EUDAMED | IVD General | Active |
| HbA1c Reagent Kits (HPLC) | 0320201002 | EUDAMED | Class A | Active |
| free TESTO (eCLIA) | 0320514703 | EUDAMED | IVD General | Active |
| Thyroglobulin (Electrochemiluminescence Immunoassay) | 690034 | EUDAMED | Class B | Active |
| HSV-I IgG (eCLIA) | 0320512703 | EUDAMED | IVD General | Active |
| Anti-CCP (eCLIA) | 0320510801 | EUDAMED | IVD General | Active |
| PCT STAT (eCLIA) | 0320510402 | EUDAMED | IVD General | Active |
| H-FABP STAT (eCLIA) | 0320511202 | EUDAMED | IVD General | Active |
| Thyroid Stimulating Hormone (TSH) Assay Kits (Lateral Flow Immunoassay) | 745013 | EUDAMED | IVD General | Active |
| Shock Wave Therapy System | NA | EUDAMED | Class IIa | Active |
| Cortisol (eCLIA) | 0320510303 | EUDAMED | IVD General | Active |
| BNP (eCLIA) | 0320511102 | EUDAMED | IVD General | Active |
| Chromatographic Column(HPLC) | 032020705 | EUDAMED | IVD General | Active |
| Cancer Antigen 125 (eCLIA) | 0320500901 | EUDAMED | Class C | Active |
| Interleukin-6 (Electrochemiluminescence Immunoassay) | 689023 | EUDAMED | IVD General | Active |
| D-dimer Assay Kit (Lateral Flow Immunoassay) | 0320303504 | EUDAMED | IVD General | Active |
| Cancer Antigen 15-3 (eCLIA) | 0320500703 | EUDAMED | IVD General | Active |
| Eluent B | 0320200503 | EUDAMED | Class A | Active |
| Thyroid stimulating hormone (Electrochemiluminescence immunoassay) | 690060 | EUDAMED | IVD General | Active |
| Hb NEXT VT80 haemolysis solution H | / | EUDAMED | Class A | Active |
| High-flow Humidification Device | / | EUDAMED | Class IIa | Active |
| Vitamin B12 (eCLIA) | 0320500203 | EUDAMED | IVD General | Active |
| ß-THALASSAEMIA & HbA1c Calibrator | 0320200201 | EUDAMED | IVD General | Active |
| Luteinizing Hormone (Electrochemiluminescence Immunoassay) | 697015 | EUDAMED | IVD General | Active |
| HS-CRP STAT (eCLIA) | 0320511403 | EUDAMED | IVD General | Active |
| BNP (eCLIA) | 0320511101 | EUDAMED | IVD General | Active |
| hCG Test (GICA) | 0320321302 | EUDAMED | IVD General | Active |
| Concentrated Washing Buffer | 679009 | EUDAMED | Class A | Active |
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