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Beijing Biosis Healing Biological Technology Co., Ltd: FDA-registered device maker in Beijing, China, 3 510(k) clearances

Name: Beijing Biosis Healing Biological Technology Co., Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Beijing Biosis Healing Biological Technology Co., Ltd is registered with the FDA (registration 3016668451) in Beijing, China. It lists 7 device types. The FDA files 3 510(k) clearances under its listings, the newest dated February 16, 2024. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3016668451
Address: 1-2F Building 1&2,No.29 Yongda Road,Daxing Bio-medicine Industry Base,Daxing District, Beijing, China, 102600
Owner or operator: Beijing Biosis Healing Biological Technology Co., Ltd (10062854)
Roles: Manufacturer
First device listed: March 12, 2020
Registered through: 2026
Brand names listed: Disposable, Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Laparoscope Trocar, Disposable Linear Cutter Stapler and Reloads, Disposable Linear Stapler and Reloads, Endoscopic Linear Cutter Stapler and Reloads, Isolation Gowns and more

Devices it lists

Device	Product code	Class	Role	Source
Accessory, Surgical Apparel	LYU	1	Manufacturer	accessdata.fda.gov
Barrier, Animal Source, Intraoral	NPL	2	Manufacturer	accessdata.fda.gov
Cover, Shoe, Operating-Room	FXP	1	Manufacturer	accessdata.fda.gov
Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	QKR	N	Manufacturer	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Manufacturer	accessdata.fda.gov
Non-Surgical Gown	OEA	1	Manufacturer	accessdata.fda.gov
Staple, Implantable	GDW	2	Manufacturer	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
February 16, 2024	K231513	Oral Matrix	NPL	Substantially Equivalent	Beijing Biosis Healing Biolog Ical Technology Co., Ltd.	accessdata.fda.gov
May 27, 2021	K201639	Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads	GDW	Substantially Equivalent	Beijing Biosis Healing Biolog Ical Technology Co., Ltd.	accessdata.fda.gov
August 6, 2020	K201641	Disposable Laparoscope Trocar	GCJ	Substantially Equivalent	Beijing Biosis Healing Biolog Ical Technology Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated February 16, 2024. 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.