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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 9 of 11
DeviceModel / ReferenceRegistriesClassStatus
Ferritin Test (FIA) 0320305502
EUDAMED
IVD GeneralActive
Cancer Antigen 15-3 (eCLIA) 0320500702
EUDAMED
Class CActive
Garment FV-14
EUDAMED
Class IActive
Heart-type Fatty Acid Binding Protein (Electrochemiluminescence immunoassay) 691023
EUDAMED
Class CActive
Parathyroid Hormone (Electrochemiluminescence Immunoassay) 693023
EUDAMED
Class BActive
Myoglobin STAT (MYO STAT) eCLIA 691035
EUDAMED
Class CActive
Temperature Management System TC-200
EUDAMED
Class IIbActive
Follicle-stimulating Hormone (Electrochemiluminescence Immunoassay) 697019
EUDAMED
IVD GeneralActive
Laminin (LN) eCLIA 692025
EUDAMED
IVD GeneralActive
Creatine Kinase MB STAT (CK-MB STAT) eCLIA 691044
EUDAMED
Class CActive
Thyroxine-binding Globulin (Electrochemiluminescence Immunoassay) 690066
EUDAMED
Class BActive
Myoglobin (Electrochemiluminescence Immunoassay) 691034
EUDAMED
Class CActive
EPO (eCLIA) 0320515004
EUDAMED
IVD GeneralActive
Cystatin C (Cys-C) Assay Kits (Lateral Flow Immunoassay) 0320301302
EUDAMED
IVD GeneralActive
Free Prostate Specific Antigen (eCLIA) 0320501004
EUDAMED
Class CActive
Microalbumin (mAlb) Assay Kits (Lateral Flow Immunoassay) 0320300601
EUDAMED
IVD GeneralActive
Anti-CCP (eCLIA) 0320510803
EUDAMED
IVD GeneralActive
Folate (Electrochemiluminescence Immunoassay) 694018
EUDAMED
IVD GeneralActive
TNF-alpha (eCLIA) 0320513501
EUDAMED
IVD GeneralActive
Serum Amyloid A (eCLIA) 0320502002
EUDAMED
IVD GeneralActive
Sleeve MAP-BE-L
EUDAMED
Class IActive
Probe Rinse Solution 0320201204
EUDAMED
Class AActive
Creatine Kinase MB STAT (CK-MB STAT) eCLIA 691043
EUDAMED
Class CActive
Garment WV-23
EUDAMED
Class IActive
Cancer Antigen 15-3 (eCLIA) 0320500704
EUDAMED
IVD GeneralActive
Anti-Mullerian Hormone(eCLIA) 697045
EUDAMED
Class BActive
Sleeve SAP-LG-S
EUDAMED
Class IActive
Free Triiodothyronine Kit (Electrochemiluminescence Immunoassay) 690059
EUDAMED
IVD GeneralActive
Anti-Mullerian Hormone(eCLIA) 697043
EUDAMED
Class BActive
ß-THALASSAEMIA & HbA1c Assay Column (HPLC) 0320208
EUDAMED
IVD GeneralActive
Insulin (Electrochemiluminescence Immunoassay) 695026
EUDAMED
Class BActive
Folate (Electrochemiluminescence Immunoassay) 694019
EUDAMED
IVD GeneralActive
Parathyroid Hormone (Electrochemiluminescence Immunoassay) 693019
EUDAMED
Class BActive
Myoglobin STAT (MYO STAT) eCLIA 691038
EUDAMED
Class CActive
Myoglobin STAT (MYO STAT) eCLIA 691036
EUDAMED
Class CActive
Lipoprotein-Associated Phospholipase A2 (Electrochemiluminescence Immunoassay) 691051
EUDAMED
Class CActive
Procollagen III N-terminal peptide (PIIINP) eCLIA 692012
EUDAMED
IVD GeneralActive
Thyroglobulin Antibody (Electrochemiluminescence Immunoassay) 690036
EUDAMED
Class BActive
HbA1c Assay Kits (Lateral Flow Immunoassay) 0320301103
EUDAMED
IVD GeneralActive
H.Pylori Ag Test (GICA) 0320320402
EUDAMED
IVD GeneralActive
Warming Blanket UN-321
EUDAMED
Class IActive
PCT STAT (eCLIA) 0320510404
EUDAMED
IVD GeneralActive
Thyroglobulin Antibody (Electrochemiluminescence Immunoassay) 690035
EUDAMED
IVD GeneralActive
Garment FV-12
EUDAMED
Class IActive
Thyroglobulin Antibody (Electrochemiluminescence Immunoassay) 690043
EUDAMED
IVD GeneralActive
Thyroid Peroxidase Antibody ( Electrochemiluminescence Immunoassay) 690040
EUDAMED
Class BActive
Eluent A 0320200509
EUDAMED
Class AActive
Procalcitonin (Electrochemiluminescence Immunoassay) 689013
EUDAMED
Class BActive
D-dimer Assay Kit (Lateral Flow Immunoassay) 0320303501
EUDAMED
IVD GeneralActive
ST2 (eCLIA) 0320514801
EUDAMED
IVD GeneralActive

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