Biosoft

33 catalogue numbers from BCAA77, listed by Coloplast A/S, Denmark, under Stent, Ureteral. 4 manufacturers in China are registered for this product code.

Registry build 21.09.26
4manufacturers in China registered for this device type
33catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (2), Zhejiang (1), Guangdong (1).

Chinese manufacturers registered for FDA product code FAD
Manufacturer City Province Registered as Device types
Zhejiang Chuangxiang Medical Technology Co., Ltd. Hangzhou Zhejiang Contract manufacturer 27
Alton Shanghai Medical Instruments Co Ltd Shanghai Shanghai Complaint-file establishment 20
BQ Plus Medical Co., Ltd. Songjiang Shanghai Contract manufacturer 13
Shenzhen Trious Medical Technology Co., Ltd. Shenzhen Guangdong Manufacturer 6

Record

Regulatory record for Biosoft
Listed by Coloplast A/S, Denmark
FDA product code FAD
Device type Stent, Ureteral
Device class Class 2
Regulation 21 CFR 876.4620
Establishment Specification developer, Manufacturer
Record published 2024-04-12

Specifications

Specifications
MRI safety MR Safe
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Latex Labelled latex-free
Label carries lot or batch number, expiry date
Storage Special storage condition: Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
Packaging Retail box, shipper box of 34
Sizes Catheter gauge 6 to 9 Fr; length 20 to 30 cm

Catalogue Numbers

Catalogue numbers for Biosoft
Catalogue number Size Status
BCAA77 Catheter Gauge 7 Fr In distribution
BCAF85 Length 28 cm In distribution
BCAA96 Length 30 cm In distribution
BCAF76 Length 30 cm In distribution
BCAF77 Length 22 cm In distribution
BCAA76 Length 30 cm In distribution
BCAF64 Length 26 cm In distribution
BCAA62 Catheter Gauge 6 Fr In distribution
BCAF72 Catheter Gauge 7 Fr In distribution
BCAA67 Length 22 cm In distribution
BCAA73 Length 24 cm In distribution
BCAA74 Catheter Gauge 7 Fr In distribution
BCAA64 Length 26 cm In distribution
BCAA94 Length 26 cm In distribution
BCAF84 Catheter Gauge 8 Fr In distribution
BCAF73 Catheter Gauge 7 Fr In distribution
BCAA86 Catheter Gauge 8 Fr In distribution
BCAA66 Length 30 cm In distribution
BCAF67 Catheter Gauge 6 Fr In distribution
BCAF86 Catheter Gauge 8 Fr In distribution
BCAA72 Length 20 cm In distribution
BCAA65 Length 28 cm In distribution
BCAF75 Catheter Gauge 7 Fr In distribution
BCAA63 Catheter Gauge 6 Fr In distribution
BCAA95 Length 28 cm In distribution
BCAF65 Length 28 cm In distribution
BCAA75 Length 28 cm In distribution
BCAA84 Length 26 cm In distribution
BCAF74 Length 26 cm In distribution
BCAF66 Catheter Gauge 6 Fr In distribution
BCAF63 Length 24 cm In distribution
BCAF62 Length 20 cm In distribution
BCAA85 Length 28 cm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Porges Coloplast Coloplast A/S 509
Polaris™ Ultra Boston Scientific Corporation 406
Universa Cook Incorporated 384
Percuflex™ Plus Boston Scientific Corporation 300
Polaris™ Loop Boston Scientific Corporation 232
ImaJin Coloplast A/S 219
Contour™ Boston Scientific Corporation 205
Percuflex™ Boston Scientific Corporation 152
Tecoflex Gyrus Acmi, Inc. 92
Vortek Coloplast A/S 92
Sof-Flex Cook Incorporated 60
Tria™ Firm Boston Scientific Corporation 58

Showing 12 of 131. All products under Stent, Ureteral

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