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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 2 of 11
DeviceModel / ReferenceRegistriesClassStatus
Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E) K251076
FDA 510(k)
Class IIActive
Warming Blanket UP-121
EUDAMED
Class IActive
Prolactin (Electrochemiluminescence Immunoassay) 697029
EUDAMED
Class BActive
Hb NEXT V60 eluent A /
EUDAMED
Class AActive
BNP (eCLIA) 0320511104
EUDAMED
IVD GeneralActive
D-Dimer STAT (eCLIA) 0320500303
EUDAMED
IVD GeneralActive
Interleukin-6 (Electrochemiluminescence Immunoassay) 689017
EUDAMED
IVD GeneralActive
Eluent B 0320202804
EUDAMED
Class AActive
Myoglobin (Myo) Assay Kits (Lateral Flow Immunoassay) 0320300801
EUDAMED
IVD GeneralActive
Laminin (LN) eCLIA 692018
EUDAMED
IVD GeneralActive
VT80 eluent B 0320200913
EUDAMED
Class AActive
Garment WV-21
EUDAMED
Class IActive
Hb NEXT eluent A /
EUDAMED
Class AActive
Influenza A&B Test (GICA) 0320304502
EUDAMED
IVD GeneralActive
Hb NEXT V60 eluent C /
EUDAMED
Class AActive
N-terminal pro B-type Natriuretic Peptide(Electrochemiluminescence Immunoassay) 691045
EUDAMED
IVD GeneralActive
HBP (eCLIA) 0320515202
EUDAMED
IVD GeneralActive
Eluent D 0320203004
EUDAMED
Class AActive
CA50 (eCLIA) 0320509403
EUDAMED
IVD GeneralActive
Heart-type Fatty Acid Binding Protein (Electrochemiluminescence immunoassay) 691024
EUDAMED
IVD GeneralActive
Malaria P.f/Pan Test (GICA) 0320321202
EUDAMED
IVD GeneralActive
H-FABP STAT (eCLIA) 0320511204
EUDAMED
IVD GeneralActive
Total Prostate Specific Antigen (eCLIA) 0320501104
EUDAMED
Class CActive
Anti-TSHR (eCLIA) 0320511301
EUDAMED
IVD GeneralActive
Serum Amyloid A (eCLIA) 0320502001
EUDAMED
IVD GeneralActive
Pepsinogen I (Electrochemiluminescence Immunoassay) 696012
EUDAMED
IVD GeneralActive
Hb NEXT V60 eluent B /
EUDAMED
Class AActive
V60 analytical column 0320201701
EUDAMED
IVD GeneralActive
ß-Human Chorionic Gonadotrophin (ß-HCG) Assay Kits (Lateral Flow Immunoassay) 745016
EUDAMED
IVD GeneralActive
Hb NEXT haemolysis solution H /
EUDAMED
Class AActive
HbA1c Control 0320301151
EUDAMED
IVD GeneralActive
Procalcitonin (Electrochemiluminescence Immunoassay) 689014
EUDAMED
IVD GeneralActive
Automated ECL Immunoassay Analyzer 0120508
EUDAMED
Class AActive
CA50 (eCLIA) 0320509401
EUDAMED
IVD GeneralActive
25-Hydroxy Vitamin D Test (FIA) 0320305402
EUDAMED
IVD GeneralActive
Hemoglobin Analyzer(HPLC) NA
EUDAMED
Class AActive
Microalbumin (mAlb) Assay Kits (Lateral Flow Immunoassay) 745006
EUDAMED
IVD GeneralActive
MPO (eCLIA) 0320509203
EUDAMED
IVD GeneralActive
ß-THALASSAEMIA & HbA1c Calibrator 56149
EUDAMED
IVD GeneralActive
Free Triiodothyronine Kit(Electrochemiluminescence Immunoassay) 690057
EUDAMED
Class BActive
FDP (eCLIA) 0320510201
EUDAMED
IVD GeneralActive
Automated ECLImmunoassay Analyzer 012130601
EUDAMED
Class AActive
Creatine Kinase MB (Electrochemiluminescence Immunoassay) 691039
EUDAMED
IVD GeneralActive
Multi Control Cardiac Marker 691027
EUDAMED
Class CActive
Total Triiodothyronine Kit (Electrochemiluminescence Immunoassay) 690051
EUDAMED
IVD GeneralActive
Heart-type Fatty Acid Binding Protein (Electrochemiluminescence immunoassay) 691025
EUDAMED
IVD GeneralActive
Total Beta Human Chorionic Gonadotropin (Total β-HCG) eCLIA 697042
EUDAMED
Class BActive
BNP (eCLIA) 0320511103
EUDAMED
IVD GeneralActive
Calcitonin (Electrochemiluminescence Immunoassay) 693026
EUDAMED
IVD GeneralActive
PROG STAT (eCLIA) 0320510603
EUDAMED
IVD GeneralActive

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