Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9710391

FEI Number

3003202124

Entity Name

POLYMED (XIAMEN) PLASTIC INDUSTRIAL CO.,LTD.

City/State/Country

XIAMEN Fujian, CN

Establishment Address

Unit B, 1-5F, No. G, Warehouse & process, complex building, XIANGYU F.T.Z., XIANGYU F.T.Z., XIAMEN Fujian 361012, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

POLYMED (XIAMEN) PLASTIC INDUSTRIAL CO.,LTD. (Owner Number: 9044088)

Owner / Operator Contact Address

Unit B, 1-5F, No. G, Warehouse & process, complex building, XIANGYU F.T.Z., XIAMEN, CN-FJ 361006, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

FLO2MAX Oxygen Mask Disposable Bag Resuscitator AEROSOL HOOD PEEP VALVE NeoNatalie Resuscitator NEBULIZER Nasal Cannula OXYGEN RESERVOIR BAG NOSE CLIP MX Type AIR SPLINT VACUM PUMP The BAG Mask OXYGEN CONCENTRATION MASK CPAP MASK ANESTHETIC MASK BREATHING CIRCUIT MANUAL RESUSCITATOR BAG TRACHEAL SWIVEL CONNECTOR NEBULIZER COMPRESSOR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2021-06-09
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2020-04-23
FOG	Hood, Oxygen, Infant	Anesthesiology	Class 1	868.5700	2001-09-20
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	Class 2	868.5965	2007-12-11
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2015-04-16
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	2001-06-18
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2008-11-26
BTC	Bag, Reservoir	Anesthesiology	Class 1	868.5320	2001-06-18
BXJ	Clip, Nose	Anesthesiology	Class 1	868.6225	2001-06-18
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2020-04-23
FZF	Splint, Extremity, Inflatable, External	General, Plastic Surgery	Class 1	878.3900	2003-08-04
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2003-08-04
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2001-06-18
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2001-06-18
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2007-12-11
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2011-08-23
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2001-06-18
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2007-12-11

Official Correspondent

EUNICE WU

US Agent Details

FANFEI LIU Email: U.S.agent@frosatechnology.com Phone: (626) 8261385

Related Public Records

Same Entity

POLYMED (XIAMEN) PLASTIC INDUSTRIAL 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
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-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.
Z-0040-2010	Unomedical	2	Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID #s: 5804; 12-8709, 727-E; 727MM, 2203. Packaged under the name of Dynarex, Evergreen, Mada and Hospitak.
Z-0041-2010	Unomedical	2	Adult Manual Pulmonary Resuscitator with reservoir tube, face mask & Gas Sampling elbow. Product ID # 5807; 12-8703, 723-E (Foreign Distribution only), 723MM. Packaged under the name of Dynarex and Evergreen.
Z-0042-2010	Unomedical	2	Adult Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID #s 5808, 12-8704; 724-E; 724MM, 32612. Packaged under the name of Dynarex, Evergreen, Hospitak and Select Medical Products.
Z-0043-2010	Unomedical	2	Adult Manual Pulmonary Resuscitator with reservoir tube, face mask & standard elbow. Product ID #: 12-8702; 778500; 721-E, 778500; 2200; 2201, 86-721E, 40-116722 (foreign distributiuon only), 721MM. Packaged under the name of Evergreen, Hospitak, Kentron, McKesson and Mada.

Similar Registrations

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9611500	Draegerwerk AG & Co. KGaA	LUEBECK Schleswig-Holstein, DE
3005460813	TAIZHOU XINKANG MEDICAL MATERIALS CO., LTD	Taizhou Jiangsu, CN
8021995	FLEXICARE MEDICAL LTD.	RHONDDA CYNON TAFF Wales, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9710391. Last updated year: 2026. Please use registration number 9710391 when referencing this establishment in official correspondence.