Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013412170

FEI Number

3013412170

Entity Name

HANGZHOU FORMED MEDICAL DEVICES CO., LTD.

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

Building 3, No. 292 Gonghe North Road, Xindeng Town, Fuyang District, Hangzhou Zhejiang 311404, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Hangzhou Formed Medical Devices Co., Ltd. (Owner Number: 10052858)

Owner / Operator Contact Address

Building 3, No. 292 Gonghe North Road, Xindeng Town, Fuyang District, Hangzhou, CN-ZJ 311404, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Catheter Fixation Device Endotracheal Tube Holder Tracheostomy Tube Holder Mucus Extractor Suction Catheter Closed Suction Catheter Suction Tubing Suction Tubing with Yankauer Handle Yankauer Suction Nasal Cannula Silicone Nasal Cannula Silicone Extension Cannula Catheter Mount Breathing Circuit Anesthesia Breathing Circuit Laryngeal Mask Oral-pharyngeal Airway Flexi 2G SAD Introducer Laryngeal Mask Introducer Guedel Airway Laryngeal Mask W/Gastirc Access

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	2024-06-20
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2024-06-20
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2024-06-20
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2021-03-19
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2016-10-13
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2016-10-13

Official Correspondent

Guo Yongxuan

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Hangzhou Formed Medical Devices 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-0007-2013	Invuity, Inc.	2	BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.
Z-0033-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube with Bird adapter, oxygen supply tubing, sideport connector with adjustable bleed valve, and 40 cm H2O Popoff elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83124-2
Z-0034-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, ported elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83100-24
Z-0035-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, 40 cm H2O Popoff elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83144-24
Z-0036-04	VIASYS Med Systems	1	Hyperinflation Circuit, consisting of a 2.0 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve and ported elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83120

Similar Registrations

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3024808683	WARRIORNP LLC	Bloomfield Hills, MI, US
1824231	ICU Medical, Inc.	Gary, IN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013412170. Last updated year: 2026. Please use registration number 3013412170 when referencing this establishment in official correspondence.