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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 7 of 11
DeviceModel / ReferenceRegistriesClassStatus
Renin (eCLIA) 0320511903
EUDAMED
IVD GeneralActive
Ferritin (Electrochemiluminescence Immunoassay) 694013
EUDAMED
IVD GeneralActive
Luteinizing Hormone (Electrochemiluminescence Immunoassay) 697017
EUDAMED
IVD GeneralActive
Hb NEXT VT80 eluent A 0320200912
EUDAMED
Class AActive
PROG Test (FIA) 0320302102
EUDAMED
IVD GeneralActive
Prolactin (Electrochemiluminescence Immunoassay) 697030
EUDAMED
Class BActive
Carcinoembryonic Antigen (eCLIA) 0320500503
EUDAMED
IVD GeneralActive
Creatine Kinase MB (CK-MB) Assay Kits (Lateral Flow Immunoassay) 0320300903
EUDAMED
IVD GeneralActive
Pepsinogen I (Electrochemiluminescence Immunoassay) 696024
EUDAMED
IVD GeneralActive
Garment FV-11
EUDAMED
Class IActive
Auffer 0320501801
EUDAMED
Class AActive
Cytokeratin Fragment 19 (eCLIA) 0320501501
EUDAMED
Class CActive
Troponin I (Electrochemiluminescence Immunoassay) 691012
EUDAMED
IVD GeneralActive
Eluent A 0320202704
EUDAMED
Class AActive
Anti-Mullerian Hormone(eCLIA) 697046
EUDAMED
IVD GeneralActive
Luteinizing Hormone (Electrochemiluminescence Immunoassay) 697018
EUDAMED
IVD GeneralActive
Thyroglobulin (Electrochemiluminescence Immunoassay) 690029
EUDAMED
IVD GeneralActive
Garment FV-21
EUDAMED
Class IActive
Chromatographic Column(HPLC) 0320205
EUDAMED
IVD GeneralActive
Insulin (Electrochemiluminescence Immunoassay) 695027
EUDAMED
Class BActive
25-OH Vitamin D Total (Electrochemiluminescence Immunoassay) 693021
EUDAMED
IVD GeneralActive
Pepsinogen I (Electrochemiluminescence Immunoassay) 696023
EUDAMED
IVD GeneralActive
Vitamin B12 (eCLIA) 0320500208
EUDAMED
IVD GeneralActive
Total Thyroxine Kit (Electrochemiluminescence Immunoassay) 690044
EUDAMED
IVD GeneralActive
free TESTO (eCLIA) 0320514704
EUDAMED
IVD GeneralActive
Thyroxine-binding Globulin (Electrochemiluminescence Immunoassay) 690067
EUDAMED
Class BActive
25-OH Vitamin D Total (Electrochemiluminescence Immunoassay) 693025
EUDAMED
IVD GeneralActive
Free Thyroxine Kit (Electrochemiluminescence Immunoassay) 690055
EUDAMED
Class BActive
Insulin Test (FIA) 0320307702
EUDAMED
IVD GeneralActive
Myoglobin (Electrochemiluminescence Immunoassay) 691015
EUDAMED
IVD GeneralActive
N-MID Osteocalcin (eCLIA) 0320510502
EUDAMED
IVD GeneralActive
High-Voltage Adjustment Buffer 679016
EUDAMED
Class AActive
N-terminal pro B-type Natriuretic Peptide STAT (NT-proBNP STAT) eCLIA 691049
EUDAMED
Class CActive
Testosterone (Electrochemiluminescence Immunoassay) 697036
EUDAMED
IVD GeneralActive
N-terminal pro B-type Natriuretic Peptide(Electrochemiluminescence Immunoassay) 691020
EUDAMED
IVD GeneralActive
Anti-CCP (eCLIA) 0320510804
EUDAMED
IVD GeneralActive
Patient Interfaces(Nasal Cannula) NA
EUDAMED
Class IIaActive
HSV-I IgG (eCLIA) 0320512702
EUDAMED
IVD GeneralActive
Hb NEXT analytical column 58643
EUDAMED
IVD GeneralActive
Insulin (Electrochemiluminescence Immunoassay) 695025
EUDAMED
IVD GeneralActive
Myoglobin (Myo) Assay Kits (Lateral Flow Immunoassay) 745008
EUDAMED
IVD GeneralActive
BNP STAT (eCLIA) 0320509704
EUDAMED
Class CActive
ALD (eCLIA) 0320511803
EUDAMED
IVD GeneralActive
V80 analytical column 0320201801
EUDAMED
IVD GeneralActive
Thyroid stimulating hormone (Electrochemiluminescence immunoassay) 690061
EUDAMED
Class BActive
Anti-TSHR (eCLIA) 0320511302
EUDAMED
IVD GeneralActive
Vitamin B12 (eCLIA) 0320500207
EUDAMED
IVD GeneralActive
Cancer Antigen 125 (eCLIA) 0320500902
EUDAMED
Class CActive
Total Triiodothyronine Kit (Electrochemiluminescence Immunoassay) 690048
EUDAMED
IVD GeneralActive
HBP (eCLIA) 0320515201
EUDAMED
IVD GeneralActive

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