Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011647251

FEI Number

3011647251

Entity Name

SHENZHEN WAP-HEALTH TECHNOLOGY CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Floor 3, Building C, The Third Industrial Zone #23, Gongming, Guangming New District, Shenzhen Guangdong 518106, CN

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Shenzhen WAP-health Technology Co., Ltd. (Owner Number: 10060544)

Owner / Operator Contact Address

Floor 3, Building C, The Third Industrial Zone #23, Gongming, Guangming New District, Shenzhen, CN-GD 518106, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cabinet WAP-health Hearing aid Bandage Valve Splint Bandage

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2020-03-03
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2024-07-10
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2020-03-03
OVR	Kit, First Aid, Talking	General, Plastic Surgery	Class 1	878.4014	2019-05-23
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2020-03-03
EPF	Hearing Aid, Group And Auditory Trainer	Ear, Nose, Throat	Class 2	874.3320	2022-06-27
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2020-03-03
CBP	Valve, Non-Rebreathing	Anesthesiology	Class 2	868.5870	2024-06-21
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2020-03-03
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	2020-03-03
IQM	Splint, Temporary Training	Physical Medicine	Class 1	890.3025	2022-06-27
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2024-08-19
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2020-03-03

Official Correspondent

Mandy Wang

US Agent Details

Qin Liu Business: Quingni Email: starhealthsz@outlook.com Phone: (917) 9458308

Related Public Records

Same Entity

Shenzhen WAP-health 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
K212801	Hong Seng Gloves Sdn Bhd	Powder free nitrile examination glove- black, non sterile	2022-01-09
K260806	Vista Industries,, LLC	Nitrile Disposable Examination Gloves	2026-06-03
K011593	Ansell Healthcare Products, Inc.	MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE	2001-06-21
K981039	Sri Johani Sdn. Bhd.	POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED)	1998-04-21
K101595	Better Care Plastic Technology Cp., Ltd.	POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE	2010-08-06

Similar Registrations

Registration Number	Establishment Name	Location
3015168527	Shenzhen Senlede Technologies Co., Ltd	Shenzhen Guangdong, CN
3018762668	PLASTI-MED PLASTIK MEDIKAL URUNLER SAN. VE TIC. LTD. STI.	Tuzla Istanbul, TR
3016678045	Schneider ASR B.V.	Rotterdam-Albrandswaard Zuid-Holland, NL
1225492	NextPhase Medical Devices LLC	ROCHESTER, NH, US
3006547005	NINGBO BESMED MEDICAL EQUIPMENT CORP.	NINGBO Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011647251. Last updated year: 2026. Please use registration number 3011647251 when referencing this establishment in official correspondence.