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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 10 of 11| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Warming Blanket | LT-417 | EUDAMED | Class I | Active |
| CA15-3 Test (FIA) | 0320307102 | EUDAMED | IVD General | Active |
| HSV-II IgM (eCLIA) | 0320512801 | EUDAMED | IVD General | Active |
| N-terminal pro B-type Natriuretic Peptide(Electrochemiluminescence Immunoassay) | 691046 | EUDAMED | IVD General | Active |
| Carbonhydrate Antigen 19-9 (eCLIA) | 0320500804 | EUDAMED | IVD General | Active |
| Eluent D | 0320200528 | EUDAMED | Class A | Active |
| C-peptide (Electrochemiluminescence Immunoassay) | 695021 | EUDAMED | Class B | Active |
| Ferritin (Electrochemiluminescence Immunoassay) | 694016 | EUDAMED | IVD General | Active |
| Vitamin B12 (eCLIA) | 0320500204 | EUDAMED | IVD General | Active |
| Testosterone (Electrochemiluminescence Immunoassay) | 697037 | EUDAMED | Class B | Active |
| HSV-I IgM (eCLIA) | 0320512601 | EUDAMED | IVD General | Active |
| Chromatographic Column(HPLC) | 0320207 | EUDAMED | Class C | Active |
| Cytokeratin Fragment 19 (eCLIA) | 0320501502 | EUDAMED | IVD General | Active |
| IGFBP-3 (eCLIA) | 0320509503 | EUDAMED | IVD General | Active |
| Hb NEXT T60 eluent B | / | EUDAMED | Class A | Active |
| Hemoglobin Analyzer(HPLC) | NA | EUDAMED | Class A | Active |
| pro-Gastrin-Releasing Peptide (eCLIA) | 0320501302 | EUDAMED | IVD General | Active |
| Procalcitonin (Electrochemiluminescence Immunoassay) | 50T | EUDAMED | IVD General | Active |
| Progesterone (Electrochemiluminescence Immunoassay) | 697022 | EUDAMED | IVD General | Active |
| IL-6 STAT (eCLIA) | 0320510103 | EUDAMED | IVD General | Active |
| Cystatin C (Cys-C) Assay Kits (Lateral Flow Immunoassay) | 745012 | EUDAMED | IVD General | Active |
| Follicle-stimulating Hormone (Electrochemiluminescence Immunoassay) | 697020 | EUDAMED | IVD General | Active |
| Renin (eCLIA) | 0320511901 | EUDAMED | IVD General | Active |
| fT3 Test (FIA) | 0320307302 | EUDAMED | IVD General | Active |
| Shock Wave Therapy System | NA | EUDAMED | Class IIa | Active |
| Carbohydrate Antigen 19-9 (eCLIA) | 0320500803 | EUDAMED | IVD General | Active |
| N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) Assay Kits (Lateral Flow Immunoassay) | 745004 | EUDAMED | IVD General | Active |
| Sleeve | SAP-SH-L | EUDAMED | Class I | Active |
| SARS-CoV-2 Nucleic Acid Detection Kit (Multiplex PCR Fluorescent Probe Method) | 528006 | EUDAMED | IVD General | Active |
| Patient Interfaces（Nasal Cannula） | NA | EUDAMED | Class IIa | Active |
| DHEA-S (eCLIA) | 0320514904 | EUDAMED | IVD General | Active |
| Gastrin-17 (eCLIA) | 0320500102 | EUDAMED | IVD General | Active |
| Total Prostate Specific Antigen (eCLIA) | 0320501103 | EUDAMED | Class C | Active |
| BNP STAT (eCLIA) | 0320509703 | EUDAMED | IVD General | Active |
| Pepsinogen II (Electrochemiluminescence Immunoassay) | 696026 | EUDAMED | IVD General | Active |
| Multi Control Cardiac Marker | 691028 | EUDAMED | IVD General | Active |
| Hb NEXT eluent C | / | EUDAMED | Class A | Active |
| hs-cTnI STAT (eCLIA) | 0320513404 | EUDAMED | IVD General | Active |
| Interleukin-6 (Electrochemiluminescence Immunoassay) | 689018 | EUDAMED | Class B | Active |
| Procalcitonin (PCT) Assay Kits (Lateral Flow Immunoassay) | 745001 | EUDAMED | IVD General | Active |
| S100 (eCLIA) | 0320509104 | EUDAMED | IVD General | Active |
| Estradiol (Electrochemiluminescence Immunoassay) | 697031 | EUDAMED | Class B | Active |
| IgE (eCLIA) | 0320511603 | EUDAMED | IVD General | Active |
| Garment | FV-10 | EUDAMED | Class I | Active |
| HbA1c Control Material | 55605 | EUDAMED | IVD General | Active |
| Myoglobin (Electrochemiluminescence Immunoassay) | 691016 | EUDAMED | Class C | Active |
| Sleeve | SAP-SH-S | EUDAMED | Class I | Active |
| HSV-II IgG (eCLIA) | 0320512901 | EUDAMED | IVD General | Active |
| CA50 (eCLIA) | 0320509402 | EUDAMED | Class C | Active |
| TNF-alpha (eCLIA) | 0320513504 | EUDAMED | IVD General | Active |
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