Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003862188

FEI Number

3003862188

Entity Name

HSINER CO., LTD.

City/State/Country

TAICHUNG CITY, TW

Establishment Address

312, Jhongshang Rd., Shengang Dist., TAICHUNG CITY 429, TW

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

HSINER CO., LTD. (Owner Number: 9053474)

Owner / Operator Contact Address

312, Jhongshang Rd., Shengang Dist., Taichung City, TW-TXG 429, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

& GAS LINE ACCESSORIES; HSINER VARIOUS MODELS OF VENTILATOR Hsiner Humidifier HSINER VARIOUS MODELS OF CPAP VPAP MASK Shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear) HSINER VARIOUS MODEL Filters & Filtered HME HSINER Anesthesia Breathing Circuit Kit (adult & pediatric) Oxygen Tubing and Accessories HSINER VARIOUS MODELS Strap, Head, Gas Mask Airway Connector HSINER CPAP SILICONE NASAL MASK SIZE XS PETITE HSINER NASAL PILLOW MASK HSINER INFANT CPAP CANNULA Venturi Mask (as part of oxygen mask group) HSINER VARIOUS MODELS OF AIRWAY Artificial Nose Pulmogine® Mouthpiece Aerosol Mouthpiece Aerogen Go® Mouthpiece Water Trap VALVE MASK COMBO HSINER VARIOUS MODELS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2007-08-27
KFZ	Humidifier, Non-Direct Patient Interface (Home-Use)	Anesthesiology	Class 1	868.5460	2008-09-06
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2007-04-13
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2021-04-07
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2002-10-22
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2009-07-31
OFP	Anesthesia Breathing Circuit Kit (Adult & Pediatric)	Anesthesiology	Class 1	868.5240	2011-09-23
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2020-05-15
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2003-02-11
BTK	Strap, Head, Gas Mask	Anesthesiology	Class 1	868.5560	2024-03-03
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2020-05-29
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2012-08-24
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	Class 1	868.5600	2024-03-03
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2002-10-22
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2009-06-07
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2025-11-28
BYH	Drain, Tee (Water Trap)	Anesthesiology	Class 1	868.5995	2024-03-03
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2010-12-20
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2007-08-27

Official Correspondent

No official correspondent registered.

US Agent Details

Shu-Chen Cheng Business: ROC Chinese-European Industrial Research Society Email: ceirs.jen@msa.hinet.net Phone: (614) 5888168

Related Public Records

Same Entity

HSINER CO., LTD.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3031369651	HSINER CO., LTD.	Taichung City, TW

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K792722	Novametrix Medical Systems, Inc.	NOVAMETRIX CPAP NASAL CANNULA	1980-01-24
K082979	Resmed, Ltd.	S8 ADVANCE	2009-01-02
K203126	Resmed Pty , Ltd.	S10 Kirra	2020-12-18
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 3003862188. Last updated year: 2026. Please use registration number 3003862188 when referencing this establishment in official correspondence.