Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031369651

FEI Number

3031369651

Entity Name

HSINER CO., LTD.

City/State/Country

Taichung City, TW

Establishment Address

No. 251, Sec.1,Houke Rd., Houli Dist., Taichung City 421, 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

Venturi Mask (as part of oxygen mask group) Pulmogine® Adult Mask Aerosol Mask Child Oxygen Mask HSINER CPR Pocket Masks Aerosol Mask Adult Aerogen Go® Mask (Pediatric) Pulmogine® Pediatric Mask Aerogen Go® Mask (Adult) HSINER VARIOUS MOD Oxygen Administration Face Tent Anesthesia Breathing Circuit Kit (adult & pediatric) HSINER VARIOUS MODELS OF CPAP VPAP MASK Artificial Nose Airway Connector Breathing Bag Strap, Head, Gas Mask HSINER VARIOUS MODELS Pulmogine® Mouthpiece Aerosol Mouthpiece Aerogen Go® Mouthpiece Hsiner Nebulizer Bottle HSINER VARIOUS MOD & GAS LINE ACCESSORIES; HSINER VARIOUS MODELS OF VENTILATOR Filters & Filtered HME HSINER Hsiner Humidifier Shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear) Oxygen Tubing and Accessories

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	Class 1	868.5600	2024-03-03
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2002-10-22
BYL	Tent, Oxygen	Anesthesiology	Class 1	868.5700	2024-03-03
OFP	Anesthesia Breathing Circuit Kit (Adult & Pediatric)	Anesthesiology	Class 1	868.5240	2011-09-23
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2007-04-13
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2009-06-07
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2020-05-29
BTC	Bag, Reservoir	Anesthesiology	Class 1	868.5320	2009-06-07
BTK	Strap, Head, Gas Mask	Anesthesiology	Class 1	868.5560	2024-03-03
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2003-02-11
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2025-11-28
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2008-09-06
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	Class 2	868.5965	2006-05-09
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2006-05-09
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2007-08-27
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2009-07-31
KFZ	Humidifier, Non-Direct Patient Interface (Home-Use)	Anesthesiology	Class 1	868.5460	2008-09-06
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2021-04-07
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2020-05-15

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
3003862188	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
K163485	Adherium (Nz), Ltd.	SmartTouch	2017-08-30
K781467	Travenol Laboratories, S.A.	U-FLOAT VALVE 2D9023	1978-09-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2020	TELEFLEX-MORRISVILLE	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
Z-0020-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
Z-0021-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
Z-0022-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802
Z-0039-2010	Unomedical	2	Infant Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID # 5801, 12-8713, 732-E, and 2206. Packaged under the name of Dynarex, Evergreen, Mada and Hospitak. Recalled codes may be identified by examining the patient valve housing immediately below the right-angle exhalation port, where the retention ring should be visible. MPR units with a clear or transparent ring, as well as those where no ring can be seen, should be returned. MPR units with a blue retention ring are not affected and do not need to be returned.

Similar Registrations

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3004134948	ZHEJIANG BAITE MEDICAL APPLIANCES CO., LTD.	Huzhou City Zhejiang, CN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031369651. Last updated year: 2026. Please use registration number 3031369651 when referencing this establishment in official correspondence.