Curaplex

Curaplex ALS Kit, BTM Sales Rep, incl Halo Seal, Burn Sheet, LMA, Blankets, Neb, Mask, Cannula, etc.

Registry build 21.09.26
60manufacturers in China registered for this device type
70catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (16), Zhejiang (15), Shanghai (11). 12 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FMF
Manufacturer City Province Registered as Device types
Jiangsu Caina Medical Co., Ltd. Jiangyin Jiangsu Contract manufacturer 20
BQ Plus Medical Co., Ltd. Songjiang Shanghai Contract manufacturer 13
Medwell Technology Limited Dongguan Guangdong Contract manufacturer 10
Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. Chengdu Sichuan Contract manufacturer 10
Zhejiang Runqiang Medical Instruments Co., Ltd. Jiaxing Zhejiang Contract manufacturer 9
Wuxi Yushou Medical Appliances Co., Ltd. Wuxi Jiangsu Contract manufacturer 8
Pine Moon Electronics Co., Ltd. Shenzhen Guangdong Contract manufacturer 8
Shenzhen HYS Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 6
Yangzhou Xingwei Medical Technology Co., Ltd. Yangzhou Jiangsu Contract manufacturer 5
Zhejiang INI Medical Devices Co., Ltd. Wenzhou Zhejiang Contract manufacturer 4
ShanDong WeiGao Group Medical Polymer Co., Ltd. Weihai Shandong Contract manufacturer 3
Hantech (Ningbo) Medical Technology Co., Ltd. Ningbo Zhejiang Contract manufacturer 3

Showing 12 of 60. All 60 manufacturers in China registered for Syringe, Piston

Record

Regulatory record for Curaplex
Listed by Bound Tree Medical, LLC, United States
FDA product code FMF
Device type Syringe, Piston
Device class Class 2
Regulation 21 CFR 880.5860
Establishment Manufacturer
Premarket notification Exempt
Record published 2019-12-30
Record revised 2023-12-06 (version 8)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Latex Contains natural rubber latex
Label carries lot or batch number, expiry date
Packaging Case of 25, pack of 10, case of 20, case of 100, case of 50, case of 10
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Curaplex
Catalogue number Size Status
8600-01430 In distribution
36613 In distribution
351215 In distribution
2114-040815-KIT In distribution
2114-11001 In distribution
2114-04081-KIT In distribution
8600-01431 In distribution
2114-04084-KIT In distribution
8600-01281 In distribution
8600-01101 In distribution
2114-12002 In distribution
023080S In distribution
8600-01102 In distribution
8600-01279 In distribution
8600-10CCSY-1439 In distribution
8600-01313 In distribution
8600-01309 In distribution
680155-KIT In distribution
2114-04082-KIT In distribution
8600-01279 In distribution
8600-01307 In distribution
8600-01120 In distribution
36614 In distribution
12186 In distribution
8600-01432 In distribution
8600-01169 In distribution
8600-01276 In distribution
8600-01212 In distribution
680154-KIT In distribution
2114-04086-KIT In distribution
8600-01124 In distribution
8600-01311 In distribution
8600-01278 In distribution
8600-01312 In distribution
2114-14004 In distribution
8600-01278 In distribution
8600-SL1MLS-1436 In distribution
2114-040825-KIT In distribution
2115-01975 In distribution
8600-01211 In distribution
2114-13003 In distribution
301-670252-KIT In distribution
2525-01094 In distribution
670005-KIT In distribution
2114-15005 In distribution
8600-01121 In distribution
8600-SG1MLS-1437 In distribution
2114-04085-KIT In distribution
8600-01276 In distribution
301-0206 In distribution
8600-01308 In distribution
8600-01275 In distribution
6840155C In distribution
8600-01280 In distribution
2114-04083-KIT In distribution
8600-01205 In distribution
8600-01123 In distribution
8600-SL3MLS-1438 In distribution
8600-01280 In distribution
2115-01980 In distribution
8600-03CCSY-1440 In distribution
6840155STK In distribution
8600-01310 In distribution
8600-01210 In distribution
8600-01205 In distribution
8600-01100 In distribution
8600-01277 In distribution
2525-16050 In distribution
8600-01281 In distribution
8600-01277 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Yeso med Wuxi Yushou Medical Appliances Co., Ltd. 228
Medallion® Merit Medical Systems, Inc. 223
Merit Medical® Merit Medical Systems, Inc. 192
Monoject Cardinal Health 188
Medline Medline Industries, Inc. 127
EasyTouch MHC Medical Products 122
Medline Industries, Inc. Medline Industries, Inc. 99
Arrow Teleflex Medical LLC 94
Ceros Rhino Medical Supply Inc 92
Enteral Feeding Medela LLC 87
Monoject Cardinal Health 200, LLC 83
HSW Soft-Ject® Henke-Sass Wolf, Gmbh. 80

Showing 12 of 913. All products under Syringe, Piston

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