Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009093866

FEI Number

3009093866

Entity Name

Hangzhou Tappa Medical Technology Co., Ltd.

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

Room 2002, Building 1, Chutian Technology Building, No. 225 Chutian Road, Xixing Street, Binjiang District, Hangzhou Zhejiang 310000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Hangzhou Tappa Medical Technology Co.,Ltd (Owner Number: 10055101)

Owner / Operator Contact Address

Room 2002, Building 1, Chutian Technology Building, No. 225 Chutian Road, Xixing Street, Binjiang District, Hangzhou, CN-ZJ 310000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K252861

PMA Number

N/A

All Registered Proprietary Names

EBT0209S Endobronchial Blocker Tube EBT0109 EBT0105S EBT0207 EBT0105 EBT0107 EBT0207S EBT0205 EBT0205S EBT0109S EBT0107S EBT0209 Laryngeal Mask Airway Warming System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CBI	Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)	Anesthesiology	Class 2	868.5740	2026-03-23
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2017-06-07
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2026-04-13

Official Correspondent

Xiaobo Wen

US Agent Details

Wei ZHANG Business: 3dstocking Inc Email: ge@3dstocking.com Phone: (772) 9996108

Related Public Records

Same Entity

Hangzhou Tappa Medical 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
K071694	Daiken Medical Co, Ltd.	COOPDECH ENDOBRONCHIAL BLOCKER TUBE, MODELS BBT-A30XXX, BBT-B30XXX	2008-03-20
K171373	3M Company	3M Bair Hugger Model 675 Total Temperature Management System	2017-10-10
K083336	Smiths Medical Asd, Inc.	LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1 SNUGGLE WARM LEFT LATERAL	2009-06-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2014	King Systems Corp.	1	King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.
Z-0035-2010	Cincinnati Sub-Zero Products Inc	2	WarmAir 135 Thermal Regulating System. Catalog Numbers: 86186-115 V, 06186-115 V (sold in the U.S.) and #86185-100 V ( not sold in the U.S.). Intended for warming patients before, during and after surgery, and other specialty procedures.

Similar Registrations

Registration Number	Establishment Name	Location
1820334	Cook Incorporated	Bloomington, IN, US
3006984712	HENAN TUOREN MEDICAL DEVICE CO., LTD.	Changyuan Henan, CN
3012307300	ICU Medical, Inc.	Minneapolis, MN, US
3007134520	TELEFLEX MEDICAL	ATHLONE Westmeath, IE
3004748541	Salter Labs	El Paso, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009093866. Last updated year: 2026. Please use registration number 3009093866 when referencing this establishment in official correspondence.