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Shenzhen 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
LinkedIn
—
Facebook
—
Phone
0086-755-29060026
PRRC Contact
Minyi Pei
EUDAMED SRN
CN-MF-000005654
FDA FEI Number
—
DUNS Number
—

Catalogue (549)

Page 8 of 11
DeviceModel / ReferenceRegistriesClassStatus
HSV-II IgM (eCLIA) 0320512802
EUDAMED
IVD GeneralActive
Cancer Antigen 15-3 (eCLIA) 0320500701
EUDAMED
IVD GeneralActive
Lipoprotein-Associated Phospholipase A2 (Electrochemiluminescence Immunoassay) 691053
EUDAMED
Class CActive
Total Triiodothyronine Kit(Electrochemiluminescence Immunoassay) 690050
EUDAMED
Class BActive
Collagen Type IV (CIV) eCLIA 692022
EUDAMED
IVD GeneralActive
C-peptide (Electrochemiluminescence Immunoassay) 695023
EUDAMED
IVD GeneralActive
hGH (eCLIA) 0320509602
EUDAMED
IVD GeneralActive
Anti-CCP (eCLIA) 0320510802
EUDAMED
IVD GeneralActive
High-Sensitivity Troponin T STAT (hs-cTnT STAT) eCLIA 691030
EUDAMED
IVD GeneralActive
Hb NEXT T80 eluent C 55046
EUDAMED
Class AActive
AMH Test (FIA) 0320303002
EUDAMED
IVD GeneralActive
N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) Assay Kits (Lateral Flow Immunoassay) 0320300403
EUDAMED
IVD GeneralActive
Progesterone (Electrochemiluminescence Immunoassay) 697021
EUDAMED
Class BActive
Sleeve SAP-RH-M
EUDAMED
Class IActive
Pro-Gastrin-Releasing Peptide (eCLIA) 0320501301
EUDAMED
IVD GeneralActive
Total Thyroxine Kit (Electrochemiluminescence Immunoassay) 690046
EUDAMED
IVD GeneralActive
Auffer 679005
EUDAMED
Class AActive
Human Epididymal Protein 4 (eCLIA) 0320500604
EUDAMED
IVD GeneralActive
Ferritin (Electrochemiluminescence Immunoassay) 694014
EUDAMED
Class BActive
Cholylglycine (CG) eCLIA 692016
EUDAMED
IVD GeneralActive
Dengue IgG/IgM Antibody Test (GICA) 0320321002
EUDAMED
IVD GeneralActive
Lp-PLA2 STAT (eCLIA) 0320511501
EUDAMED
IVD GeneralActive
Assay Cup 679012
EUDAMED
Class AActive
Free Thyroxine Kit (Electrochemiluminescence Immunoassay) 690052
EUDAMED
IVD GeneralActive
Interleukin-6 (Electrochemiluminescence Immunoassay) 689024
EUDAMED
IVD GeneralActive
Free Thyroxine Kit (Electrochemiluminescence Immunoassay) 690053
EUDAMED
IVD GeneralActive
Hb NEXT T60 eluent A /
EUDAMED
Class AActive
N-terminal pro B-type Natriuretic Peptide STAT (NT-proBNP STAT) eCLIA 691047
EUDAMED
IVD GeneralActive
Thyroglobulin (Electrochemiluminescence Immunoassay) 690033
EUDAMED
IVD GeneralActive
Thyroid Peroxidase Antibody ( Electrochemiluminescence Immunoassay) 690042
EUDAMED
Class BActive
Canister CL500
EUDAMED
Class IActive
ß-THALASSAEMIA & HbA1c Reagent Kit (HPLC) 0320201205
EUDAMED
Class AActive
Automated ECLImmunoassay Analyzer 0120515
EUDAMED
Class AActive
PRL Test (FIA) 0320302802
EUDAMED
IVD GeneralActive
Sleeve MAP-LC-M
EUDAMED
Class IActive
Automated ECLImmunoassay Analyzer 0120512
EUDAMED
Class AActive
Gastrin-17 (eCLIA) 0320500103
EUDAMED
IVD GeneralActive
Neuronen-Spezifische Enolase (eCLIA) 0320501603
EUDAMED
Class CActive
Sleeve SAP-SH-S
EUDAMED
Class IActive
Measuring Cell Maintenance Buffer 0320507104
EUDAMED
Class AActive
Warming Blanket FU-221
EUDAMED
Class IActive
Garment WV-25
EUDAMED
Class IActive
Testosterone (Electrochemiluminescence Immunoassay) 697035
EUDAMED
IVD GeneralActive
Chromatographic Column(HPLC) 0320214
EUDAMED
IVD GeneralActive
Cancer Antigen 72-4 (eCLIA) 0320501701
EUDAMED
Class CActive
Lipoprotein-Associated Phospholipase A2 (Electrochemiluminescence Immunoassay) 691054
EUDAMED
Class CActive
Estradiol (Electrochemiluminescence Immunoassay) 697032
EUDAMED
Class BActive
Hb NEXT T60 eluent C \
EUDAMED
Class AActive
Assay Cup/Assay Tip 032120111
EUDAMED
Class AActive
Real time PCR Kit for Monkeypox Virus 529012/529013
EUDAMED
IVD GeneralActive

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