Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016668451

FEI Number

3016668451

Entity Name

BEIJING BIOSIS HEALING BIOLOGICAL TECHNOLOGY CO., LTD

City/State/Country

Beijing, CN

Establishment Address

1-2F Building 1&2,No.29 Yongda Road,Daxing Bio-medicine Industry Base,Daxing District, Beijing 102600, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Beijing Biosis Healing Biological Technology Co., Ltd (Owner Number: 10062854)

Owner / Operator Contact Address

1-2F Building 1&2,No.29 Yongda Road,Daxing Bio-medicine Industry Base,Daxing District, Beijing, CN-BJ 102600, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Medical Shoe cover Disposable Circular Staple Disposable Linear Cutter Stapler and Reloads Disposable Linear Stapler and Reloads Disposable Hemorrhoidal Stapler Disposable Endoscopic Linear Cutter Stapler and Reloads Oral Matrix Isolation Gowns Medical Protective clothing Disposable Laparoscope Trocar Medical Goggle Medical Face Shield Protective Goggle Medical Face Mask

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2020-04-22
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2022-02-11
NPL	Barrier, Animal Source, Intraoral	Dental	Class 2	872.3930	2025-02-26
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-03-12
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2022-02-11
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-24
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2020-03-30

Official Correspondent

Ting Jiang

US Agent Details

Marco Mu Business: MID-LINK INTERNATIONAL CO., LTD Email: us.agent@mid-link.net Phone: (702) 2095185

Related Public Records

Same Entity

Beijing Biosis Healing Biological Technology Co., Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K131563	Opus Ksd, Inc.	SUBQ IT! BIOABSORBABLE SKIN CLOSURE SYSTEM	2014-04-09
K131705	Covidien, Formerly US Surgical A Divison of Tyco H	ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY	2013-07-01
K103263	Covidien, Formerly US Surgical A Divison of Tyco H	ENDO GIA SINGLEUSE DUET TRS RELOAD WITH TRI0STAPLE TECHNOLOGY	2010-11-22
K130717	Covidien, Formerly US Surgical A Divison of Tyco H	ENDO GIA RELOAD	2013-04-18
K221006	Covidien	GIA Stapler with Tri-Staple Technology	2022-04-29

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2021	N/A	2	Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, Item Code 030450 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0002-2021	N/A	2	Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 2.5 mm, Item Code 030451 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0003-2021	N/A	2	Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 3.5 mm, Item Code 030452 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0004-2021	N/A	2	Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0005-2021	N/A	2	Endo GIA Auto Suture Universal Loading Unit 45 mm - 2.5mm, Item Code 030454 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

Similar Registrations

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3038718579	OKETZ LOGISTICS LLC	Coral Gables, FL, US
3008808082	PLANET(SHANGHAI) INTERNATIONAL CO.,LTD	shanghai, CN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016668451. Last updated year: 2026. Please use registration number 3016668451 when referencing this establishment in official correspondence.