Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008427684

FEI Number

3008427684

Entity Name

NINGBO FIRST IMPORT & EXPORT CO., LTD.

City/State/Country

NINGBO Zhejiang, CN

Establishment Address

RM. 601, NO. 500, TAIKANG MIDDLE ROAD, YINZHOU DISTRICT, NINGBO Zhejiang 315000, CN

Establishment Type(s)

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

Owner / Operator

NINGBO FIRST IMPORT AND EXPORT COMPANY LIMITED (Owner Number: 10034975)

Owner / Operator Contact Address

RM601, NO.500 TAIKANG MIDDLE ROAD,, YINZHOU DISTRICT, NINGBO, CN-ZJ 315100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Elastic Bandage, First aid bandage BEDDING Emergency Blanket Alcohol pre pad Tourniquet Face Shield SCISSORS, MEDICAL, DISPOSABLE DEPRESSOR SHEET, BURN GAUZE/SPONGE Mouth to mouth shield, Mouthpiece, CPR Mask SNAKE BITE SYRINGE contained in SNAME BITE KIT Face mask Gauze/sponge,nonresorbable for external use Combine Pad COVER, MATTRESS (MEDICAL PURPOSES) APPLICATOR PAD, EYE First aid kit with drug First aid bag Face Shield Cold Pack DRESS, SURGICAL Non-surgical isolation gown GOWN, EXAMINATION GARMENT, PROTECTIVE, FOR INCONTINENCE Toothbrush DRESSING, COMPRESSION Disinfectant, medical devices CRUTCH Compressed ANSl Tri Bandage, Triangular Bandage Tape and bandage, adhesive Trauma Pad, Non-adherent Pad, Chest Seal, Vented, ABD pad, Trauma pads

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2013-07-25
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2011-01-21
LKB	Pad, Alcohol, Device Disinfectant	Unknown	Class U	N/A	2024-11-22
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2016-01-12
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2020-04-21
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	2011-01-21
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2011-01-21
FPY	Sheet, Burn	General Hospital	Class 1	880.5180	2011-01-21
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2011-01-21
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2013-07-25
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2015-11-18
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2020-03-16
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2011-01-21
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2016-04-20
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2011-01-21
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2011-01-21
HMP	Pad, Eye	General, Plastic Surgery	Class 1	878.4440	2011-01-21
LRR	First Aid Kit With Drug	Unknown	Class N	N/A	2025-08-14
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2016-01-13
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2020-04-23
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2025-04-23
FYE	Dress, Surgical	General, Plastic Surgery	Class 1	878.4040	2011-01-21
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2011-01-21
FME	Gown, Examination	General Hospital	Class 1	880.6265	2011-01-21
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2011-01-21
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2013-07-25
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2011-01-21
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2011-01-21
IPR	Crutch	Physical Medicine	Class 1	890.3150	2011-01-21
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2025-04-23
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2011-01-21
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2025-04-23

Official Correspondent

JENNIFER LIU

US Agent Details

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

Related Public Records

Same Entity

NINGBO FIRST IMPORT AND EXPORT COMPANY 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
K790050	Stanford Professional Products	SPONGES, STANFORD STERILE LAP	1979-01-17
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019	COVIDIEN LLC	1	Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

Similar Registrations

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3005360866	QEL DOMINICANA S.A.	ESPERANZA Valverde, DO
3015414796	COMPRESS INNOVATIONS, LLC	Manhasset, NY, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008427684. Last updated year: 2026. Please use registration number 3008427684 when referencing this establishment in official correspondence.