Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007649127

FEI Number

3007649127

Entity Name

Zhejiang Medtec Medical devices Co., Ltd

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

No 77 Yangdai Rd, Linan Hangzhou, Hangzhou Zhejiang 55364, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Zhejiang Medtec Medical devices Co., Ltd (Owner Number: 10028750)

Owner / Operator Contact Address

No 77 Yangdai Rd, Linan Hangzhou, Hangzhou, CN-ZJ 311301, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Nebulizer without mask Nebulizer with mask Nebulizer hand held MedSource I.V. Administration Set High Concentrate NRB Mask Non-Rebreather with vent Tee Aerosol Mask, Oxygen Curaplex Total Non-Rebreather Mask Oxygen nonrebreather Mask Oxygen, Nonrebreather Non-Rebreather, w/ Univ. Conn Non-Rebreather Yankaeur Tip & Tube, Non-Vented Yankaeur Tip only, Vented Yankaeur Tube only Yankaeur Tip & Tube, Vented Yankaeur Tube only, Vented Yankaeur Tip only, Non-Vented CPR barrier Catheter Oxygen Mask Elongated Aerosol Mask under chin Trah Mask Kit All Diluters, U Conn Tracheostomy Mask No tubing Oxygen Mask Aerosol Mask Elongated Venturi Mask Kit All Diluters Aerosol Mask Under Lip No Tubing Oxygen Mask U. Conn.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	2009-03-03
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2013-01-02
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2009-03-03
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2009-03-03
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2026-03-16
BZB	Catheter, Nasal, Oxygen	Anesthesiology	Class 1	868.5350	2010-12-16
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2012-08-27

Official Correspondent

No official correspondent registered.

US Agent Details

Emilie Andrews Business: MedSource International, LLC. Email: eandrews@medsourcelabs.com Phone: (952) 4720131

Related Public Records

Same Entity

Zhejiang Medtec Medical devices Co., Ltd

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
K243985	Icu Medical, Inc.	Rio Drug Reconstitution Transfer Device	2025-01-22
K222718	Hangzhou Qiantang Longyue Biotechnology Co., Ltd.	Vial Adapter	2023-03-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2017	Baxter Corporation Englewood	2	0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.

Similar Registrations

Registration Number	Establishment Name	Location
9710020	ZHEJIANG ANJI HUABU INDUSTRIAL CO., LTD.	HUZHOU Zhejiang, CN
3007502289	Laboratorios PiSA, S. A. de C.V.	Tlajomulco de Zuniga Jalisco, MX
9611283	DIMEDA INSTRUMENTE GMBH	TUTTLINGEN Baden-Wurttemberg, DE
9613910	NARANG MEDICAL, LTD.	New Delhi, IN
3003898360	Teleflex Medical de Tecate, S. de R.L de C.V.	TECATE Baja California, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007649127. Last updated year: 2026. Please use registration number 3007649127 when referencing this establishment in official correspondence.