Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027617478

FEI Number

3027617478

Entity Name

ANPING GUARDIAN MEDICAL EQUIPMENT CO.,LTD

City/State/Country

Hengshui Hebei, CN

Establishment Address

500 Meters Suxin Road, NanSu Cun, Hengshui Hebei 053600, CN

Establishment Type(s)

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

Owner / Operator

Anping Guardian Medical Equipment Co.,Ltd (Owner Number: 10088234)

Owner / Operator Contact Address

500 Meters Suxin Road, NanSu Cun, Hengshui, CN-HE 053600, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Alcohol cotton ball Decompression Needle CPR mask Personal Protective Equipment TAPE AND BANDAGE.ADHESIVE, Medical Tape MEDICAL, Emergency Blanket Nasopharyngeal airway Dressing, wound, hydrogel without drug and/or biologic, Burn Dressing Cervical Collars; Extrication Collar Shears Pelvic Belt Flotation Cushion Trauma Dressing, Kaolin Hemostatic Gauze Pelvic Suport Eye Shield Head Immobilizer Chest Seal Stretcher Splint

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2024-12-23
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2023-06-15
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2024-12-23
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2023-06-15
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2023-06-15
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2023-06-15
BTQ	Airway, Nasopharyngeal	Anesthesiology	Class 1	868.5100	2023-06-15
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2023-06-15
IQF	Orthosis, Cervical-Thoracic, Rigid	Physical Medicine	Class 1	890.3490	2023-06-15
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	2023-06-15
HSQ	Belt, Pelvic, Traction	Orthopedic	Class 1	888.5890	2023-06-15
KIC	Cushion, Flotation	Physical Medicine	Class 1	890.3175	2023-06-15
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2023-06-15
ISR	Band Or Belt, Pelvic Support	Physical Medicine	Class 1	890.3025	2023-06-15
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2025-09-09
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2023-06-15
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2023-06-15
FPP	Stretcher, Hand-Carried	General Hospital	Class 1	880.6900	2023-06-15
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2023-06-15

Official Correspondent

Xingmei Zhao

US Agent Details

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

Related Public Records

Same Entity

Anping Guardian Medical Equipment 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
K781371	Ferris Mfg. Corp.	BONE MARROW ASPIRATION KIT	1978-09-20
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-0017-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620
Z-0018-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle Catalog Number: 4621
Z-0023-2011	Becton Dickinson & Company	1	BD 30G1/2 PrecisionGlide Needle;Catalog/Lot Number: 305106. Needles are intended for use in aspiration and injection of medications.
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027617478. Last updated year: 2026. Please use registration number 3027617478 when referencing this establishment in official correspondence.