Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3032597249

FEI Number

3032597249

Entity Name

ANERTAI INDUSTRIAL LIMITED

City/State/Country

Dongguan Guangdong, CN

Establishment Address

Room 203,#18 Heng Heng Road,Chashan Town, Dongguan Guangdong 523000, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

ANERTAI Industrial Limited (Owner Number: 10091376)

Owner / Operator Contact Address

Room 203,#18 Heng Heng Road,Chashan Town, Dongguan, CN-GD 523000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

FIRST AID KIT WITH DRUG PACK, HOT OR COLD, DISPOSABLE FIRST AID KIT WITHOUT DRUG TAPE AND BANDAGE, ADHESIVE GAUZE / SPONGE,NONRESORBABLE FOR EXTERNAL USE BANDAGE, ELASTIC DEPRESSOR, TONGUE, NON-SURGICAL GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE FORCEPS PAD, EYE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRR	First Aid Kit With Drug	Unknown	Class N	N/A	2024-09-10
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2024-09-10
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2024-09-10
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2024-09-10
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2024-09-10
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2024-09-10
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2024-09-10
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2024-09-10
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2024-09-10
HMP	Pad, Eye	General, Plastic Surgery	Class 1	878.4440	2024-09-10

Official Correspondent

Gary Li

US Agent Details

Wilson Cheung Business: Ksquaredcapital LLC Email: Wilson.Cheung.FDA@gmail.com Phone: (716) 9655112

Related Public Records

Same Entity

ANERTAI Industrial Limited

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
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223

Similar Registrations

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3009095935	SHENZHEN INTRA INDUSTRY DBA SBI SMART BRANDS INTERNATIONAL [AMERICA]	Shenzhen City Guangdong, CN
1320537	FIELDTEX PRODUCTS, INC.	ROCHESTER, NY, US
3027244997	MyDormDoc LLC/Industrial Logistics	Amarillo, TX, US
3013545043	ECOLAB FOOD SAFETY SPECIALTIES INC.	Fort Worth, TX, US
3014679991	Safran Aerosystems Mexico S. de R.L. de C.V.	Chihuahua, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3032597249. Last updated year: 2026. Please use registration number 3032597249 when referencing this establishment in official correspondence.