Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011587055

FEI Number

3011587055

Entity Name

SHAOXING UNDIS MEDICAL TECHNOLOGY COMPANY LIMITED

City/State/Country

Shaoxing Zhejiang, CN

Establishment Address

No.12 Yuexing Technology Park, No.11 Fanrong Road, Binhai New Area, Innovation Park,No.398 Mahuan Road,, Shaoxing Zhejiang 312366, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SHAOXING UNDIS MEDICAL TECHNOLOGY COMPANY LIMITED (Owner Number: 10048510)

Owner / Operator Contact Address

No. 12 Yuexing Technology Park, Fanrong Road, Binhai New Area, Shaoxing city,, Shaoxing, CN-ZJ 312366, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Catheter, Suction Catheter, Yankauer Suction Handle/Tubing, Closed Suction System System, reading, television, closed-circuit CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE) ACCESSORY, SURGICAL APPAREL CONNECTOR, CATHETER Nebulizer, Nebulizer Mask, Nebulizer T-type, Nebulizer kit, Tracheostomy Mask Nebulizer AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY MASK, GAS, ANESTHETIC Silicone/SEBS/PVC Manual Resuscitators Manual Resuscitators(mask, PEEP valve, oxygen tube, reservoir bag, mouth opener, airway, Manometer) Mask, Oxygen Mask, Oxygen Mask with CO2 Sampling Line, Non-rebreathing Oxygen Mask, Venturi Mask, Adjustable Venturi Mas TUBING, PRESSURE AND ACCESSORIES Non-surgical isolation gown BAG, RESERVOIR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2019-08-11
HJG	System, Reading, Television, Closed-Circuit	Ophthalmic	Class 1	886.5820	2015-01-21
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2017-03-31
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-22
GCD	Connector, Catheter	General, Plastic Surgery	Class 1	878.4200	2017-03-23
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	2017-03-23
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2017-04-10
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2015-01-21
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2021-07-26
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2015-01-21
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2017-09-22
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-03-22
BTC	Bag, Reservoir	Anesthesiology	Class 1	868.5320	2017-03-23

Official Correspondent

XIAOJIAN ZENG

US Agent Details

Richard B Kennedy Business: Richard B Kennedy Email: rkennedy@trinitymdi.com Phone: (973) 2650766

Related Public Records

Same Entity

SHAOXING UNDIS MEDICAL TECHNOLOGY COMPANY LIMITED

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K920069	Innoventions, Inc.	MAGNI-CAM	1992-03-02

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.

Similar Registrations

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3011237770	Vygon Verneuil	Verneuil En Halatte Oise, FR
3016734145	CREATE BIOTECH CO., LTD.	Taoyuan City, TW

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011587055. Last updated year: 2026. Please use registration number 3011587055 when referencing this establishment in official correspondence.