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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 4 of 11
DeviceModel / ReferenceRegistriesClassStatus
25-OH Vitamin D Total (Electrochemiluminescence Immunoassay) 693011
EUDAMED
Class BActive
Lp-PLA2 STAT (eCLIA) 0320511502
EUDAMED
IVD GeneralActive
Human Epididymal Protein 4 0320500602
EUDAMED
Class CActive
Sleeve MAP-AC-M
EUDAMED
Class IActive
Sleeve MAP-LC-L
EUDAMED
Class IActive
Thyroglobulin Antibody (Electrochemiluminescence Immunoassay) 690068
EUDAMED
Class BActive
Assay Cup 679011
EUDAMED
Class AActive
Warming Blanket MA-421
EUDAMED
Class IActive
Temperature Management System TC-150
EUDAMED
Class IIbActive
Concentrated Washing Buffer 679008
EUDAMED
Class AActive
N-terminal pro B-type Natriuretic Peptide(Electrochemiluminescence Immunoassay) 691019
EUDAMED
IVD GeneralActive
Triiodothyronine (T3) Assay Kits (Lateral Flow Immunoassay) 745015
EUDAMED
IVD GeneralActive
C-Peptide Test (FIA) 0320307802
EUDAMED
IVD GeneralActive
Myoglobin (Myo) Assay Kits (Lateral Flow Immunoassay) 0320300802
EUDAMED
IVD GeneralActive
N-MID Osteocalcin (eCLIA) 0320510504
EUDAMED
IVD GeneralActive
Free Triiodothyronine Kit(Electrochemiluminescence Immunoassay) 690058
EUDAMED
Class BActive
Hb NEXT V80 eluent C 55045
EUDAMED
Class AActive
Microalbumin (mAlb) Assay Kits (Lateral Flow Immunoassay) 0320300603
EUDAMED
IVD GeneralActive
Free Triiodothyronine Kit(Electrochemiluminescence Immunoassay) 690056
EUDAMED
Class BActive
Automated ECLImmunoassay Analyzer 012130301
EUDAMED
Class AActive
C-peptide (Electrochemiluminescence Immunoassay) 695022
EUDAMED
Class BActive
Myoglobin (Electrochemiluminescence Immunoassay) 691033
EUDAMED
Class CActive
HSV-I IgM (eCLIA) 0320512604
EUDAMED
IVD GeneralActive
High-Sensitivity C-reactive Protein ( Electrochemiluminescence Immunoassay) 689011
EUDAMED
IVD GeneralActive
Creatine Kinase MB (Electrochemiluminescence Immunoassay) 691017
EUDAMED
Class CActive
N-terminal pro B-type Natriuretic Peptide STAT (NT-proBNP STAT) eCLIA 691048
EUDAMED
Class CActive
C-reactive Protein (CRP) Assay Kits (Lateral Flow Immunoassay) 745012
EUDAMED
IVD GeneralActive
H-FABP STAT (eCLIA) 0320511201
EUDAMED
IVD GeneralActive
High-Sensitivity Troponin T STAT (hs-cTnT STAT) eCLIA 691032
EUDAMED
IVD GeneralActive
ß-THALASSAEMIA & HbA1c Assay Column (HPLC) 0320209
EUDAMED
IVD GeneralActive
Sleeve SAP-LG-XL
EUDAMED
Class IActive
Squamous Cell Carcinoma (eCLIA) 0320501204
EUDAMED
Class CActive
Squamous Cell Carcinoma (eCLIA) 0320501201
EUDAMED
IVD GeneralActive
High-Sensitivity C-reactive Protein ( Electrochemiluminescence Immunoassay) 689020
EUDAMED
Class CActive
Hemoglobin Analyzer(HPLC) NA
EUDAMED
Class AActive
Serum Amyloid A (eCLIA) 0320502003
EUDAMED
IVD GeneralActive
Warming Blanket PU-215
EUDAMED
Class IActive
PreClean 0320507502
EUDAMED
Class AActive
Parathyroid Hormone (Electrochemiluminescence Immunoassay) 693020
EUDAMED
IVD GeneralActive
Procollagen III N-terminal peptide (PIIINP) eCLIA 692019
EUDAMED
IVD GeneralActive
AFP Test (FIA) 0320306802
EUDAMED
IVD GeneralActive
Cancer Antigen 125 (eCLIA) 0320500903
EUDAMED
Class CActive
Hemolytic Agent L 0320200402
EUDAMED
Class AActive
Carcinoembryonic Antigen (eCLIA) 0320500502
EUDAMED
Class CActive
Carbonhydrate Antigen 19-9 (eCLIA) 06970341685805
EUDAMED
Class CActive
25-OH Vitamin D Total (Electrochemiluminescence Immunoassay) 693024
EUDAMED
IVD GeneralActive
Ferritin (Electrochemiluminescence Immunoassay) 694015
EUDAMED
IVD GeneralActive
Testosterone (Electrochemiluminescence Immunoassay) 697038
EUDAMED
Class BActive
Total Triiodothyronine Kit(Electrochemiluminescence Immunoassay) 690049
EUDAMED
Class BActive
Estradiol Test (FIA) 0320307502
EUDAMED
IVD GeneralActive

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