Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010889742

FEI Number

3010889742

Entity Name

SHAOXING HAITECH MEDICAL PRODUCTS CO., LTD

City/State/Country

SHAOXING Zhejiang, CN

Establishment Address

No.201, Building 4, 1423 Renmin East Road, SHAOXING Zhejiang 312035, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shaoxing Haitech Medical Products Co., Ltd (Owner Number: 10046508)

Owner / Operator Contact Address

No.201, Building 4, 1423 Renmin East Road, Shaoxing, CN-ZJ 312035, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ENDOTRACHEAL TUBE HOLDER 880541 CATHETER MOUNT; 880551.10; 880551.11; 880551.12 HME FILTER; 880530; 880531; 880530.C; 880530.B; 880530.10; 880530TA; 880530TB DISPOSABLE BACTERIAL VIRAL FILTER; 880529; 880529HB HT-98010; HT-98011; HT-98012; HT-98013; HT-98014 DISPOSABLE IRRIGATION SYRINGE BREATHING BAG 880522; 880523; 880524; 880525; 880526; 880527; 880543 SKIN STAPLE REMOVER HT-31 Breathing circuit bacterial/viral filter 880541TS; 880541TM; 880541TL; 880541TXL TRACHEOTOMY TUBE HOLDER DISPOSABLE ANAESTHESIA BREATHING CIRCUITS 880501; 880504; 880508 CLOSED SUCTION CATHETER/SYSTEM 8805505A; 8805506A; 8805508A; 880550.10A; 880550.12A; 880550.14A; 880550.16A; 880550.18A 7880550.10A; 7880550.12A; 7880550.14A; 7880550.16A NASAL OXYGEN CANNULA 1810002

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JAY	Support, Breathing Tube	Anesthesiology	Class 1	868.5280	2015-01-09
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2014-03-31
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2014-03-31
BYW	Device, Rebreathing	Anesthesiology	Class 1	868.5675	2014-03-31
GDT	Staple, Removable (Skin)	General, Plastic Surgery	Class 1	878.4760	2015-01-09
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2024-02-27
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	2015-01-09
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2014-03-31
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2014-03-31
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2022-11-24

Official Correspondent

Sunny Zhao

US Agent Details

Alex Gary Business: BTS US Inc Email: us@hibts.com Phone: (844) 9823583

Related Public Records

Same Entity

Shaoxing Haitech Medical Products 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
K962045	Mallinckrodt Medical	ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT	1996-11-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
Z-0037-04	VIASYS Med Systems	1	Sideport Kit, consisting of an adjustable sideport valve and an O2 port elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83166

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010889742. Last updated year: 2026. Please use registration number 3010889742 when referencing this establishment in official correspondence.