Hangzhou Bever Medical Devices Co., Ltd.

Manufacturer and brand owner in Hangzhou, Zhejiang, China. 3 device types, 1 product catalogued, 4 clearances.

Registry build 21.09.26

Hangzhou Bever Medical Devices Co., Ltd. is a specification developer holding a current FDA establishment registration. The registration covers Catheter, Straight, Catheter, Urethral and 1 other device type. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2010.

3device types registered with the FDA
1product
4510(k) clearances
1recall

Registration

FDA registration record for Hangzhou Bever Medical Devices Co., Ltd.
Status Registered
Registration expires 2026
Registration number 3008729910
FEI number 3008729910
DUNS 528185295
Establishment type Specification developer, Manufacturer

Chinese Registration

Chinese company register details for Hangzhou Bever Medical Devices Co., Ltd.
Chinese legal name 杭州博菲医疗器械有限公司
Source Baidu Baike

Location

Address of Hangzhou Bever Medical Devices Co., Ltd.
City Hangzhou
Province Zhejiang
Address Building 2, No. 1-1, Houmuqiao
Postal code 311121
Country China

What It Makes

Device types Hangzhou Bever Medical Devices Co., Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Airway, Nasopharyngeal Class 1 Robertazzi Nasopharyngeal Airway, Nasopharyngeal Airway 2010 52
Catheter, Straight Class 2 Ready-to-Use Hydrophilic Catheter, BD Ready-to-Use Hydrophilic Catheter 2020 21
Catheter, Urethral Class 2 Ready-to-Use Hydrophilic Catheter, BD Ready-to-Use Hydrophilic Catheter, BD Intermittent Catheter, Intermittent Catheter 2012 11

Own-Brand Listings

Devices catalogued by Hangzhou Bever Medical Devices Co., Ltd.
Product Code Catalogue numbers
BD Intermittent GBM 24

Clearances

510(k) clearances naming Hangzhou Bever Medical Devices Co., Ltd. or its listings
Clearance Decision date Product code Route Held by
K192468 2019-11-27 GBM Traditional This company
K111401 2012-07-19 BTR Traditional This company
K111406 2012-07-19 BTR Traditional This company
K111405 2012-02-13 GBM Traditional This company

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls naming Hangzhou Bever Medical Devices Co., Ltd.
Initiated FDA class Root cause Reason Quantity
2025-11-29 Class II Labeling Change Control Labeling error, Incorrect expiration date 149310 units

From the Company

Published by the company on its own website, not by the FDA.

Information published by Hangzhou Bever Medical Devices Co., Ltd.
Founded 2008
Employees 51-100
Factory area 2,000+ square meters
Main products Intermittent catheters, Nasopharyngeal airways, Suction catheters, Endotracheal tubes, Feeding tubes
Certifications CE, FDA-ready, ISO 13485
Export markets 30+ countries
OEM and ODM Offered

Nearby Manufacturers

Other registered manufacturers in the same city
Manufacturer Device types
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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.

The manufacturer named here can complete this record.

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.

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2,581device types they are registered for
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