Promisemed Hangzhou Meditech Co., Ltd.

Address:No. 1388 Cangxing Street,,Hangzhou Zhejiang,CN

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- Catalog Number :

Device Description : The products are sterile with aSterility Assurance Level (SAL) of 10-6, non-pyro The products are sterile with aSterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. Each type hasseveral models. Different models are distinguished by needle gauge and length.The Common Type Insulin Pen Needle consists of needle container, needle shield, needle tube,needle hub, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and thesilicone oil is used to needle tube lubrication.The products are for OTC use, andthey are external communication, blood indirect devices. The contact duration for both subjecteddevices is within 24h, and they belong to limited contact device according ISO 10993-1.

Device Class :

Duns Number: 421335278

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 100

- Catalog Number :

Device Description : The products are sterile with aSterility Assurance Level (SAL) of 10-6, non-pyro The products are sterile with aSterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. Each type hasseveral models. Different models are distinguished by needle gauge and length.The Common Type Insulin Pen Needle consists of needle container, needle shield, needle tube,needle hub, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and thesilicone oil is used to needle tube lubrication.The products are for OTC use, andthey are external communication, blood indirect devices. The contact duration for both subjecteddevices is within 24h, and they belong to limited contact device according ISO 10993-1.

Device Class :

Duns Number: 421335278

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 100

- Catalog Number :

Device Description : The products are sterile with aSterility Assurance Level (SAL) of 10-6, non-pyro The products are sterile with aSterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. Each type hasseveral models. Different models are distinguished by needle gauge and length.The Common Type Insulin Pen Needle consists of needle container, needle shield, needle tube,needle hub, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and thesilicone oil is used to needle tube lubrication.The products are for OTC use, andthey are external communication, blood indirect devices. The contact duration for both subjecteddevices is within 24h, and they belong to limited contact device according ISO 10993-1.

Device Class :

Duns Number: 421335278

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 100

- Catalog Number :

Device Description : The products are sterile with aSterility Assurance Level (SAL) of 10-6, non-pyro The products are sterile with aSterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. Each type hasseveral models. Different models are distinguished by needle gauge and length.The Common Type Insulin Pen Needle consists of needle container, needle shield, needle tube,needle hub, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and thesilicone oil is used to needle tube lubrication.The products are for OTC use, andthey are external communication, blood indirect devices. The contact duration for both subjecteddevices is within 24h, and they belong to limited contact device according ISO 10993-1.

Device Class :

Duns Number: 421335278

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 110

- Catalog Number :

Device Description : The products are sterile with aSterility Assurance Level (SAL) of 10-6, non-pyro The products are sterile with aSterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. Each type hasseveral models. Different models are distinguished by needle gauge and length.The Common Type Insulin Pen Needle consists of needle container, needle shield, needle tube,needle hub, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and thesilicone oil is used to needle tube lubrication.The products are for OTC use, andthey are external communication, blood indirect devices. The contact duration for both subjecteddevices is within 24h, and they belong to limited contact device according ISO 10993-1.

Device Class :

Duns Number: 421335278

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 210

- Catalog Number :

Device Description : The products are sterile with aSterility Assurance Level (SAL) of 10-6, non-pyro The products are sterile with aSterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. There hasseveral models. Different models are distinguished by needle gauge and length.The Blood Lancet consists of needle tube and needle hub. The products are for OTC use, andthey are external communication, blood indirect devices. The contact duration for both subjecteddevices is within 24h, and they belong to limited contact device according ISO 10993-1.

Device Class :

Duns Number: 421335278

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 100

- Catalog Number :

Device Description : The products are sterile with aSterility Assurance Level (SAL) of 10-6, non-pyro The products are sterile with aSterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. There hasseveral models. Different models are distinguished by needle gauge and length.The Blood Lancet consists of needle tube and needle hub. The products are for OTC use, andthey are external communication, blood indirect devices. The contact duration for both subjecteddevices is within 24h, and they belong to limited contact device according ISO 10993-1.

Device Class :

Duns Number: 421335278

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 300

- Catalog Number :

Device Class :

Duns Number: 421335278

Premarket Exempt : No

Product Code : FMK

Prescription Use : No

Device Count : 50

- Catalog Number :

Device Class : 2

Duns Number: 421335278

Premarket Exempt : No

Product Code : FMK

Prescription Use : No

Device Count : 50

- Catalog Number :

Device Description : The Sharps container is single-use, disposable, non-sterile containers intended The Sharps container is single-use, disposable, non-sterile containers intended to be used for health- care purposes for safe disposal of hazardous sharps such as needles, syringes, lancets and etc. The target population is for qualified personnel in health care facilities and other facilities in which medical sharps may be used. It is made of injection molded polypropylene plastic, and is composed of base, lid, closure and handle (except pocket collectors). No part of the container is intended to come in contact with patients and the sharps objects that will be placed within the containers.

Device Class :

Duns Number: 421335278

Premarket Exempt : No

Product Code : MMK

Prescription Use : No

Device Count : 3