Home 28 Medical Devices Receive Shanghai Regulatory Approval; Company Files IPO Prospectus

28 Medical Devices Receive Shanghai Regulatory Approval; Company Files IPO Prospectus

Nov 20, 2025 17:03 CST Updated 17:03
Byron

PETIA (Particle-Enhanced Immunoturbidimetric Assay) R&D and Production Manufacturer

SHAONAO-TECH

Non-invasive brain-computer interface technology product development, production, and sales

MediWorks

Ophthalmic Product Manufacturer

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Shanghai Drug Administration Notice [2025] No. 32

In October 2025, the Shanghai Medical Products Administration approved the initial registration of 28 medical device products (specific products are listed in the attachment).

Hereby announced.

Attachment: Catalog of Medical Device Products Approved for Registration in October 2025


Shanghai Medical Products Administration

November 5, 2025


(Publication Scope: Proactive Disclosure)


Attachment

Catalog of Medical Device Products Approved for Registration in October 2025

Serial Number

Product Name

Registrant Name

Registration Certificate Number

1

Total Immunoglobulin E Assay Kit (Turbidimetric Latex Immunoassay)

Byron Diagnostics (Shanghai) Co., Ltd.

Shanghai Medical Device Registration Certificate No. 20252400432

2

Continuous Passive Motion Device for Hand Joints

SHAONAO-TECH

Shanghai Medical Device Registration Certificate No. 20252190433

3

Surgical Microscope

Shanghai Mediworks Precision Instruments Co.,Ltd.

Shanghai Medical Device Registration Certificate No. 20252060434

4

Ophthalmic Optical Biometer

Shanghai Ruiying Medical Technology Co.,Ltd.

Shanghai Medical Device Registration Certificate No. 20252160435

5

Surgical Microscope

Shanghai Mediworks Precision Instruments Co.,Ltd.

Shanghai Medical Device Registration Certificate No. 20252060436

6

Surgical Microscope

Shanghai Mediworks Precision Instruments Co.,Ltd.

Shanghai Medical Device Registration Certificate No. 20252060437

7

Endoscope Cold Light Source

Huger

Shanghai Medical Device Registration Certificate No. 20252060438

8

Scoliosis Assistive Rehabilitation Training Software

Shanghai Zhengji Medical Technology Co., Ltd.

Shanghai Medical Device Registration Certificate No. 20252210439

9

Disposable Pulse Oximetry Probe

Shanghai Puyi Medical Instrument Co., Ltd.

Shanghai Medical Device Registration Certificate No. 20252070440

10

Disposable Pen Injector

Shanghai Beilaifei Technology Co., Ltd.

Shanghai Medical Device Registration Certificate No. 20252140442

11

Disposable Stone Retrieval Basket

Shanghai Wilson Photoelectric Instruments Co., Ltd.

Shanghai Medical Device Registration Certificate No. 20252020443

12

Disposable Pen Injector

Shanghai Beilaifei Technology Co., Ltd.

Shanghai Medical Device Registration Certificate No. 20252140444

13

Disposable Cutting Blade

Shanghai Jin Hai Pai Li Ya Medical Technology Co., Ltd.

Shanghai Medical Device Registration Certificate No. 20252040445

14

Customized Orthodontic Appliance

Shanghai Rendo Medical Device Co., Ltd.

Shanghai Medical Device Registration Certificate No. 20252170446

15

Hydrophilic Coated Ureteral Stent Set

Shanghai Huodian Medical Equipment Co., Ltd.

Shanghai Medical Device Registration Certificate No. 20252140447

16

Disposable Pulse Lavage Suction Kit

Shanghai Ruizhi Medical Device Co., Ltd.

Shanghai Medical Device Registration Certificate No. 20252140448

17

Electric Bone Tissue Surgical Equipment

Shanghai Jinchuang Medical Device Manufacturing Co., Ltd.

Shanghai Medical Device Registration Certificate No. 20252040449

18

Cochlear Implant Adjustment Tool

Shanghai Hualing Artificial Ear Medical Technology Co., Ltd.

Shanghai Medical Device Registration Certificate No. 20252120450

19

Moxibustion Device

ZhiAi Medical Devices (Shanghai) Co., Ltd.

Shanghai Medical Device Registration Certificate No. 20252200451

20

Multi-Joint Endoscopic Suturing Needle Holder

Shanghai Shengzhi Medical Technology Co., Ltd.

Shanghai Medical Device Registration Certificate No. 20252020452

21

Electromyography Evoked Potential Instrument

Shanghai Qianye Medical Equipment Co., Ltd.

Shanghai Medical Device Registration Certificate No. 20252070453

22

Electric Comprehensive Operating Table

Shanghai Yida Medical Equipment Co., Ltd.

Shanghai Medical Device Registration Certificate No. 20252150454

23

Electric Hydraulic Operating Table

BenQ Sinfonia Medical Devices (Shanghai) Co., Ltd.

Shanghai Medical Device Registration Certificate No. 20252150455

24

Embryo Incubator

Shanghai Qiubei Medical Technology Co., Ltd.

Shanghai Medical Device Registration Certificate No. 20252180456

25

Carcinoembryonic Antigen, Cytokeratin 19 Fragment, Neuron-Specific Enolase, Squamous Cell Carcinoma Antigen, Gastrin-Releasing Peptide Precursor Assay Kit (Flow Fluorescence Luminescence Method)

Shanghai Tellgen Life Science Co., Ltd.

Shanghai Medical Device Registration Certificate No. 20252400457

26

Prolactin Assay Kit (Chemiluminescence Method)

DiaSorin Diagnostic Medical Equipment (Shanghai) Co., Ltd.

Shanghai Medical Device Registration Certificate No. 20252400458

27

Electric Hydraulic Operating Table

BenQ Sinfonia Medical Equipment (Shanghai) Co., Ltd.

Shanghai Medical Device Registration Certificate No. 20252150459

28

Electric Hydraulic Operating Table

BenQ Sinfonia Medical Devices (Shanghai) Co., Ltd.

Shanghai Medical Device Registration Certificate No. 20252150460






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