Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009745997

FEI Number

3009745997

Entity Name

FENGHUA TEALMED EMERGENCY PRODUCTS CO.,LTD.

City/State/Country

Ningbo Zhejiang, CN

Establishment Address

No.22 ZonYan Road, Xikou, Fenghua, Ningbo Zhejiang 315512, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Fenghua Tealmed Emergency Products Co.,Ltd. (Owner Number: 10041457)

Owner / Operator Contact Address

No.22 ZonYan Road, Xikou, Fenghua,, Ningbo, CN-ZJ 315512, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

STETHOSCOPE, MANUAL OTOSCOPE BAND OR BELT, PELVIC SUPPORT BASIN, EMESIS LIGHT, EXAMINATION, MEDICAL, BATTERY POWERED SCISSORS, GENERAL, SURGICAL SPLINT, HAND, AND COMPONENTS BEDDING, DISPOSABLE, MEDICAL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2018-08-19
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2022-08-29
ISR	Band Or Belt, Pelvic Support	Physical Medicine	Class 1	890.3025	2016-11-25
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2012-07-26
KYT	Light, Examination, Medical, Battery Powered	General Hospital	Class 1	880.6350	2018-08-19
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2023-12-21
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2012-09-26
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2012-09-26

Official Correspondent

Mike Yuan

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Fenghua Tealmed Emergency Products 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
K932506	Rudolf Riester GmbH & Co. KG	RI-SCOPE (S)	1993-10-08

Similar Registrations

Registration Number	Establishment Name	Location
3009154535	WENZHOU KANGSHUN MEDICAL DEVICES CO.,LTD.	Wenzhou City Zhejiang, CN
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3031192529	Zhejiang LuDe Technology Development Co., Ltd.	Wenzhou Zhejiang, CN
3042481106	SMART HEALTH LLC	Owings Mills, MD, US
3025413691	BESTREAT SAFETY & FIRST AID SOLUTION CO., LTD	Wuhan Hubei, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009745997. Last updated year: 2026. Please use registration number 3009745997 when referencing this establishment in official correspondence.