Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004992992

FEI Number

3004992992

Entity Name

TIANJIN MEDIS MEDICAL DEVICE CO., LTD.

City/State/Country

TIANJIN, TIANJIN, CN

Establishment Address

No.15-A, Saida One Avenue, Xiqing Economic Development Area, TIANJIN, TIANJIN 300385, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TIANJIN MEDIS MEDICAL DEVICE CO., LTD. (Owner Number: 9070069)

Owner / Operator Contact Address

No.15-A, Saida One Avenue Xiqing Economic Development Area, TIANJIN, TIANJIN, CN-TJ 300385, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K182548

PMA Number

N/A

All Registered Proprietary Names

Precurved Laryngeal Mask Reinforced Laryngeal Mask Laryngeal mask, Silicone/PVC Flowguard Laryngeal Mask 100% Silicone Laryngeal mask V Cuff Laryngeal Mask WydeGlyde laryngeal Mask Endotracheal Tube Introducer (Bougie) Runnels Steerable Introducer Accucuff Cuff Pressure Indicator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2005-02-03
BSR	Stylet, Tracheal Tube	Anesthesiology	Class 1	868.5790	2015-09-09
BSK	Cuff, Tracheal Tube, Inflatable	Anesthesiology	Class 2	868.5750	2019-02-14

Official Correspondent

DAVID ZOU

US Agent Details

James Wang Business: LLINS TECHNOLOGY INC Email: fda-rep@llins-tech.com Phone: (720) 2171916

Related Public Records

Same Entity

TIANJIN MEDIS MEDICAL DEVICE CO., LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2014	King Systems Corp.	1	King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.
Z-0006-2014	H & H Associates	2	H&H Emergency Cricothyrotomy Kit (Part No. HHECT01/ HHECTK01, NSN 6515-01-573-0692), vacuum sealed and packaged in a 5 mil poly bags, labeled in part *H & H Associates, Inc. CAGE 1NNH6 www.gohandh.com Ordinary, VA 23131 (800) 326-5708*. The product is used to maintain fracture alignment.

Similar Registrations

Registration Number	Establishment Name	Location
3037007211	ARETE MEDICAL DEVICES	Mullica Hill, NJ, US
3012508471	P3 MEDICAL LTD	Bristol Bristol, City of, GB
3014829416	MCMURRAY MEDICAL	Minneapolis, MN, US
3015314035	Bio-Med Healthcare Products Pvt. Ltd.	Palwal Haryana, IN
3008281139	DANYANG XINYA VALVE CO., LTD.	Danyang Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004992992. Last updated year: 2026. Please use registration number 3004992992 when referencing this establishment in official correspondence.