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Hangzhou Bever Medical Devices Co., Ltd.: FDA-registered device maker in Hangzhou Zhejiang, China, 2 510(k) clearances

Name: Hangzhou Bever Medical Devices Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Hangzhou Bever Medical Devices Co., Ltd. is registered with the FDA (registration 3008729910) in Hangzhou Zhejiang, China. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 27, 2019. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3008729910
Address: Building 2, No. 1-1, Houmuqiao Yongle Village, Cangqian Street, Yuhang District, Hangzhou Zhejiang, China, 311121
Owner or operator: Hangzhou Bever Medical Devices Co., Ltd. (10034111)
Roles: Specification developer
First device listed: November 5, 2010
Registered through: 2026
Brand names listed: BD Intermittent Catheter, BD Ready-to-Use Hydrophilic Catheter, Intermittent Catheter, Nasopharyngeal Airway, Ready-to-Use Hydrophilic Catheter, Robertazzi Nasopharyngeal Airway

Devices it lists

Device	Product code	Class	Role	Source
Airway, Nasopharyngeal	BTQ	1	Specification developer	accessdata.fda.gov
Catheter, Straight	EZD	2	Specification developer	accessdata.fda.gov
Catheter, Urethral	GBM	2	Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
November 27, 2019	K192468	Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Pediatric, Nelaton-tip Ready-to-Use Hydrophilic Catheter Intermittent Catheter; Male, Tapered-Tip Tiemann Ready-to-Use Hydrophilic Catheter; Male, Olive-Tip Tiemann Ready-to-Use Hydrophilic Catheter	GBM	Substantially Equivalent	Hangzhou Bever Medical Devices Co., Ltd.	accessdata.fda.gov
February 13, 2012	K111405	BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER,	GBM	Substantially Equivalent	Hangzhou Bever Medical Devices Co., Ltd.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
November 29, 2025	98147	Class II	Ongoing	BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF: RTU14F	Labeling error, Incorrect expiration date	accessdata.fda.gov

Compare with other makers

Updated January 12, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.