Bedal

Non Sterilized

Registry build 21.09.26
33manufacturers in China registered for this device type
12catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (18), Zhejiang (9), Guangdong (3). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KGZ
Manufacturer City Province Registered as Device types
Conod Medical Co., Limited Changshu Jiangsu Contract manufacturer 48
Principle & Will Biotech (Pinghu) Co., Ltd. Pinghu Zhejiang Contract manufacturer 39
Ningbo Luke Medical Devices Co., Ltd. Yuyao Zhejiang Contract manufacturer 27
Conod Medical Shuyang Co., Ltd. Shuyang Jiangsu Contract manufacturer 22
Changzhou DSB Medical Co., Ltd. Changzhou Jiangsu Contract manufacturer 16
Alleva Medical (D.G.) Ltd Dongguan Guangdong Contract manufacturer 13
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Jiangsu NEW Pentastar Medical Products Co., Ltd. Changzhou Jiangsu Exporter 146
Huzhou Junda Industry Co., Ltd. Anji Zhejiang Contract manufacturer 129
GRI Medical & Electronic Technology Co., Ltd. Jiaxing Zhejiang Contract manufacturer 71
Sterigenics Shanghai ETO Ltd. Shanghai Shanghai Contract manufacturer 65
Guangzhou Nuoning Medical Supplies Co., Ltd. Guangzhou Guangdong Contract manufacturer 62

Showing 12 of 33. All 33 manufacturers in China registered for Accessories, Catheter

Record

Regulatory record for Bedal
Listed by Bedal International NV, Belgium
FDA product code KGZ
Device type Accessories, Catheter
Device class Class 1
Regulation 21 CFR 878.4200
Establishment Manufacturer
Premarket notification Exempt
Record published 2022-03-31
Record revised 2025-12-04 (version 3)

Specifications

Specifications
MRI safety MR Conditional
Sterilisation Radiation Sterilization
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date
Storage Storage environment temperature 10 to 30 °C; Storage environment temperature 50 to 86 °F
Packaging Box of 50, t box of 400, box of 25, t-box of 200, t box of 200, box of 75
Sizes Length 70 to 95 mm; width 38.8 to 60 mm; height 6.3 to 15 mm
Distribution end date 2023-12-07

Catalogue Numbers

Catalogue numbers for Bedal
Catalogue number Size Status
bedal flex XS Length 93.9 mm In distribution
bedal flex M Length 94.1 mm In distribution
bedal picc/cvc Length 78 mm In distribution
bedal air S Length 78 mm In distribution
bedal picc/cvc Length 78 mm In distribution
bedal flex S Length 87.6 mm In distribution
bedal flex S Length 87.6 mm In distribution
bedal air S Length 78 mm In distribution
bedal flex XS Length 93.9 mm In distribution
bedal flex M Length 94.1 mm In distribution
bedal pivc Length 70 mm In distribution
bedal flex epi/pnb Length 95 mm Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
MedDrain Armm, Inc. 77
Silicone Drainage Tube Fortune Medical Instrument Corp. 74
Typenex Wound Drainage Typenex Medical, LLC 56
Cook Cook Incorporated 49
Marina Medical Marina Medical Instruments, Inc. 48
Curaplex Bound Tree Medical, LLC 36
Mediplus Mediplus Ltd. 29
AlliedSil™ Silicone Tubing Implantech Associates, Inc. 24
Arrow Teleflex Medical LLC 23
Silicone Thoracic Catheters Atrium Medical Corporation 21
Neff Cook Incorporated 18
Silhouette Cook Incorporated 16

Showing 12 of 111. All products under Accessories, Catheter

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