Nfuze

54 catalogue numbers from MKN000, listed by BQ Plus Medical Co., Ltd., China, under Set, Administration, Intravascular. 49 manufacturers in China are registered for this product code.

Registry build 21.09.26
49manufacturers in China registered for this device type
54catalogue numbers in this listing
3510(k) clearances naming this product code

Who Else Makes It

Concentrated in Zhejiang (12), Jiangsu (11), Shanghai (10). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FPA
Manufacturer City Province Registered as Device types
Promisemed Hangzhou Meditech Co., Ltd. Hangzhou Zhejiang Contract manufacturer 21
Hantech Medical Device Co., Ltd. Cixi Zhejiang Contract manufacturer 18
Forefront Medical Technology (Jiangsu) Co., Ltd. Changzhou Jiangsu Contract manufacturer 14
BQ Plus Medical Co., Ltd. Songjiang Shanghai Contract manufacturer 13
Ningbo Tianyi Medical Appliance Co., Ltd. Ningbo Zhejiang Contract manufacturer 11
Anhui Tiankang Medical Technology Co., Ltd. Tianchang Anhui Contract manufacturer 9
Anhui Kangda Medical Products Co., Ltd. Tianchang Anhui Contract manufacturer 7
JDI Electronics Factory Dongguan Guangdong Contract manufacturer 7
Yangzhou Xingwei Medical Technology Co., Ltd. Yangzhou Jiangsu Contract manufacturer 5
Wenzhou K.L.F. Medical Plastics Co., Ltd. Wenzhou Zhejiang Contract manufacturer 4
Advance Technology Ltd Shenzhen Guangdong Contract manufacturer 3
Weihai Jierui Medical Products Co., Ltd. Weihai Shandong Contract manufacturer 3

Showing 12 of 49. All 49 manufacturers in China registered for Set, Administration, Intravascular

Record

Regulatory record for Nfuze
Listed by BQ Plus Medical Co., Ltd., China
FDA product code FPA
Device type Set, Administration, Intravascular
Device class Class 2
Regulation 21 CFR 880.5440
Establishment Contract manufacturer, Contract steriliser, Manufacturer
Record published 2022-05-17
Record revised 2025-12-01 (version 5)

Specifications

Specifications
MRI safety MR Safe
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date
Distribution end date 2022-08-13

Catalogue Numbers

Catalogue numbers for Nfuze
Catalogue number Size Status
MKN000 In distribution
PFS103 In distribution
MSN002 In distribution
EJN002 In distribution
ELN002 In distribution
MSN002 In distribution
MSN002 In distribution
EJN004 In distribution
CSN002 In distribution
SS300 In distribution
MJN002 In distribution
MLN002 In distribution
MLN002 In distribution
SS300 In distribution
PFS103 In distribution
EJN004 In distribution
ELN002 In distribution
MLN002 In distribution
CSN002 In distribution
PFS103 In distribution
MJN002 In distribution
MKN000 In distribution
PVS203 In distribution
CSN002 In distribution
EJN004 In distribution
EJN002 In distribution
MJN002 In distribution
MKN000 In distribution
ELN002 In distribution
SS300 In distribution
EJN002 In distribution
BCS203 Withdrawn
BNS103 Withdrawn
BNS103 Withdrawn
PVS203 Withdrawn
PCS303 Withdrawn
ERN000 Withdrawn
PNS003 Withdrawn
ERN000 Withdrawn
ERN000 Withdrawn
PRS401 Withdrawn
PNS003 Withdrawn
HNS003 Withdrawn
PNS003 Withdrawn
PCS303 Withdrawn
PRS401 Withdrawn
PVS203 Withdrawn
BCS203 Withdrawn
BNS103 Withdrawn
PCS303 Withdrawn
PRS401 Withdrawn
BCS203 Withdrawn
HNS003 Withdrawn
HNS003 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
ICU Medical ICU Medical, Inc 529
Codan Codan US Corp. 510
Vygon Vygon Corp. 355
Port Access Needle Bard Access Systems, Inc. 341
Set, Administration, Intravascular Mps Medical, Inc. 291
Alaris, SmartSite BD Switzerland Sàrl 266
IV Administration Set B. Braun Medical Inc. 242
Medex ICU Medical, Inc 237
Extension Set B. Braun Medical Inc. 171
MaxGuard BD Switzerland Sàrl 150
Medline Medline Industries, Inc. 148
Centurion Centurion Medical Products Corporation 145

Showing 12 of 768. All products under Set, Administration, Intravascular

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K242126 2024-08-22
K223645 2023-05-18
K210381 2021-08-14

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer