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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 6 of 11
DeviceModel / ReferenceRegistriesClassStatus
Hyaluronic Acid (eCLIA) 692029
EUDAMED
IVD GeneralActive
Human Epididymal Protein 4 0320500603
EUDAMED
Class CActive
Eluent A 0320202706
EUDAMED
Class AActive
Parathyroid Hormone (Electrochemiluminescence Immunoassay) 693022
EUDAMED
IVD GeneralActive
Buffer 0320501904
EUDAMED
Class AActive
Human Epididymal Protein 4 (eCLIA) 0320500601
EUDAMED
IVD GeneralActive
VT80 eluent A 0320200912
EUDAMED
Class AActive
Follicle-stimulating Hormone (Electrochemiluminescence Immunoassay) 697025
EUDAMED
Class BActive
Cardiac Troponin (cTnI) Assay Kits (Lateral Flow Immunoassay) 0320300502
EUDAMED
IVD GeneralActive
Cytokeratin Fragment 19 (eCLIA) 0320501504
EUDAMED
Class CActive
Anti-Mullerian Hormone(eCLIA) 697044
EUDAMED
Class BActive
Prolactin (Electrochemiluminescence Immunoassay) 697028
EUDAMED
Class BActive
Creatine Kinase MB (CK-MB) Assay Kits (Lateral Flow Immunoassay) 0320300902
EUDAMED
IVD GeneralActive
Prolactin (Electrochemiluminescence Immunoassay) 697027
EUDAMED
Class BActive
Creatine Kinase MB (Electrochemiluminescence Immunoassay) 691018
EUDAMED
IVD GeneralActive
hGH (eCLIA) 0320509601
EUDAMED
IVD GeneralActive
HbA1c Reagent Kits (HPLC) 0320201003
EUDAMED
Class AActive
N-terminal pro B-type Natriuretic Peptide STAT (NT-proBNP STAT) eCLIA 691050
EUDAMED
IVD GeneralActive
pro-Gastrin-Releasing Peptide (eCLIA) 0320501303
EUDAMED
Class CActive
C-peptide (Electrochemiluminescence Immunoassay) 695011
EUDAMED
Class BActive
FDP (eCLIA) 0320510203
EUDAMED
IVD GeneralActive
High-Sensitivity C-reactive Protein ( Electrochemiluminescence Immunoassay) 689012
EUDAMED
IVD GeneralActive
Hb NEXT eluent B /
EUDAMED
Class AActive
Thyroid Peroxidase Antibody ( Electrochemiluminescence Immunoassay) 690039
EUDAMED
IVD GeneralActive
AMH Test (FIA) 0320303002
EUDAMED
IVD GeneralActive
ß-THALASSAEMIA & HbA1c Control Material 0320200702
EUDAMED
Class CActive
Tube and Chamber Kit Hi-OT3
EUDAMED
Class IIaActive
Insulin (Electrochemiluminescence Immunoassay) 695024
EUDAMED
Class BActive
High-Sensitivity Troponin T STAT (hs-cTnT STAT) eCLIA 691029
EUDAMED
IVD GeneralActive
Cancer Antigen 125 (eCLIA) 0320500904
EUDAMED
Class CActive
Garment WV-13
EUDAMED
Class IActive
Creatine Kinase MB STAT (CK-MB STAT) eCLIA 691042
EUDAMED
Class CActive
Cortisol Test (FIA) 0320307202
EUDAMED
IVD GeneralActive
Auffer 0320501804
EUDAMED
Class AActive
ß-THALASSAEMIA & HbA1c Control Material 56150
EUDAMED
IVD GeneralActive
Thyroid stimulating hormone (Electrochemiluminescence immunoassay) 690062
EUDAMED
Class BActive
Cardiac Troponin (cTnI) Assay Kits (Lateral Flow Immunoassay) 0320300503
EUDAMED
IVD GeneralActive
ALD (eCLIA) 0320511802
EUDAMED
IVD GeneralActive
Cortisol (eCLIA) 0320510301
EUDAMED
IVD GeneralActive
Estradiol (Electrochemiluminescence Immunoassay) 697033
EUDAMED
Class BActive
FSH Test (FIA) 0320302902
EUDAMED
IVD GeneralActive
Buffer 0320501906
EUDAMED
Class AActive
Heart-type Fatty Acid Binding Protein (Electrochemiluminescence immunoassay) 691026
EUDAMED
Class CActive
Tube and Chamber Kit NA
EUDAMED
Class IIaActive
Buffer 679007
EUDAMED
Class AActive
Cancer Antigen 72-4 (eCLIA) 0320501704
EUDAMED
IVD GeneralActive
V60 haemolysis solution H 0320200904
EUDAMED
Class AActive
Hypersensitivity C-reactive Protein (hs-CRP) Assay Kits (Lateral Flow Immunoassay) 0320303601
EUDAMED
IVD GeneralActive
Alpha-Fetoprotein (eCLIA) 0320501401
EUDAMED
Class CActive
Lateral Flow Immunoassay Analyzer 0120303
EUDAMED
Class AActive

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