Tianjin Medis Medical Device Co., Ltd.

Manufacturer and brand owner in Tianjin, China. 5 device types, 3 products catalogued, 3 clearances.

Registry build 21.09.26

Tianjin Medis Medical Device Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Stylet, Tracheal Tube, Airway, Nasopharyngeal and 3 other device types. 3 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2005.

5device types registered with the FDA
3products catalogued under its own name
3510(k) clearances

Registration

FDA registration record for Tianjin Medis Medical Device Co., Ltd.
Registered name TIANJIN MEDIS MEDICAL DEVICE CO., LTD.
Status Registered
Registration expires 2026
Registration number 3004992992
FEI number 3004992992
DUNS 529125266
Establishment type Contract manufacturer, Specification developer, Manufacturer

Chinese Registration

Chinese company register details for Tianjin Medis Medical Device Co., Ltd.
Chinese legal name 天津美迪斯医疗用品有限公司
Unified social credit code 911201117773303403
Source NMPA UDI database

Location

Address of Tianjin Medis Medical Device Co., Ltd.
City Tianjin
Province Tianjin
Address No.15-A, Saida One Avenue
Postal code 300385
Country China

What It Makes

Device types Tianjin Medis Medical Device Co., Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Airway, Nasopharyngeal Class 1 Nasopharyngeal Airway 2013 52
Airway, Oropharyngeal, Anesthesiology Class 1 Reinforced Laryngeal Mask, Precurved Laryngeal Mask, 100% Silicone Laryngeal mask, Laryngeal mask, Silicone/PVC, Flowguard Laryngeal Mask, V Cuff Laryngeal Mask and 1 more 2005 84
Cuff, Tracheal Tube, Inflatable Class 2 Accucuff Cuff Pressure Indicator, Disposable Endotracheal Tube, Sterile Accu CuffTM, DYNJAFLEX25~100, DYNJAFLEXU20~65 2017 6
Stylet, Tracheal Tube Class 1 Endotracheal Tube Introducer (Bougie), Runnels Steerable Introducer 2015 34
Tube, Tracheal (W/Wo Connector) Class 2 Disposable Endotracheal Tube, Sterile Accu CuffTM, DYNJAFLEX25~100, DYNJAFLEXU20~65 2017 9

Own-Brand Listings

Devices catalogued by Tianjin Medis Medical Device Co., Ltd.
Product Code Catalogue numbers
Medis BTQ 24
Medis BTR 15
Medis BSK 3

Clearances

510(k) clearances naming Tianjin Medis Medical Device Co., Ltd. or its listings
Clearance Decision date Product code Route Held by
K190274 2019-07-30 BTR Traditional This company
K182548 2019-01-25 BSK Traditional This company
K160694 2017-04-07 BTR Traditional This company

From the Company

Published by the company on its own website, not by the FDA.

Information published by Tianjin Medis Medical Device Co., Ltd.
Founded 2005
Main products nasopharyngeal airway tubes, bronchial intubation tubes, tracheal tubes
Certifications ISO 13485, CE, FDA
Export markets Europe, North America, Southeast Asia, Middle East

Nearby Manufacturers

Other registered manufacturers in the same city
Manufacturer Device types
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Tianjin Tairuibosi Medical Appliance Co., Ltd. 30
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Tianjin Water Source Tech Co., Ltd. 27
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Tianjin Medicines & Health Products IMP. & EXP. Corp. 16
Tianjin Choice Medical Device Co., Ltd. 12
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Tianjin Empecs Medical Device Co., Ltd. 8
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Tianjin Jieyaxin Medical Plastic Equipment Co., Ltd. 6
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Pranash (Tianjin) Technology Development Co., Ltd. 5
Tianjin Demax Medical Technology Co., Ltd. 5
Tianjin Jieya Women’s Hygiene Products Co., Ltd. 5
Tianjin Ethylene Oxide Sterilization Technology Co., Ltd. 4
Lights Medical Manufacture Co., Ltd. 4
Dreame Trading (Tianjin) Co., Ltd. 4
Tianjin Huada Hongyi Biotechnology Co., Ltd. 4
Tianjin Rilifine Medical Device Co., Ltd. 3
Tianjin Yiyi Hygiene Products Co., Ltd. 3
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Podo Xingda (Tianjin) Medical Co., Ltd. 3
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Reach Surgical, Inc. 1
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Sino Medical Sciences Technology Inc. 1
Novo Nordisk (China) Pharmaceuticals, Co., Ltd. 1
Yilink (Tianjin) Biotechnology Co., Ltd. 1
Tianjin Huigao Magnetics Co., Ltd. 1
Tianjin Kepler Vehicle Industry Co., Ltd. 1
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Beijing Visual Perception Intelligence Technology Co., Ltd. 1
Genobio Pharmaceutical Co., Ltd. 1
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Medinux (Tianjin) Technologies Co., Ltd. 1
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Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

The manufacturer named here can complete this record.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer