Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042251637

FEI Number

3042251637

Entity Name

GUARDMED HEALTHCARE KH CO., LTD.

City/State/Country

Bati District Takeo, KH

Establishment Address

Aopheasang Village, Kandoeng Commune, Bati District, Takeo Province, Cambodia., Bati District Takeo 210804, KH

Establishment Type(s)

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

Owner / Operator

GUARDMED HEALTHCARE KH CO., LTD. (Owner Number: 10094272)

Owner / Operator Contact Address

Aopheasang Village, Kandoeng Commune, Bati District, Takeo Province, Cambodia., Bati District, KH-21 210804, KH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

DRESSING; Foam Wound Dressing; OCCLUSIVE; WOUND Arm Guard Ostomy Pouch; Stomal Bag Dressing Eye Shield, Protective Goggles Finger Guard ADHESIVE; Elastic Adhesive Bandage; Elastic Tape; First-aid case; Kinesio Tape; Kinesiology tape and Kinezio tape; TAPE Knee Guard Orthosis, Limb Brace First Aid Kit Face Mask, Face Shield, Eye Shield Earflaps Guard Jockstrap Shoulder Pad Chest Guard Medical External Fixation Splint Sterile Eye Pad Disposable Face Mask; Disposable Surgical Mask; Medical Face Mask Elbow Brace; Wrist Brace; Palm Guard NECK STRAP /HEAD STRAP/ULTRA STRAP Hydrocolloid Dressing Leg Guard Mouth Guard (Tooth protection) Elastic Bandage

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2025-11-20
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2025-11-20
GDS	Bag, Stomal	Gastroenterology, Urology	Class 1	876.5900	2025-11-20
ILD	Adaptor, Dressing	Physical Medicine	Class 1	890.5050	2025-11-20
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2025-11-20
LQX	Device, Finger-Sucking	Physical Medicine	Class 1	890.3475	2025-11-20
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2025-11-20
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2025-11-20
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2026-02-26
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2025-11-20
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2025-11-20
EWE	Protector, Hearing (Circumaural)	Unknown	Class U	N/A	2025-11-20
FQJ	Support, Scrotal, Therapeutic	General Hospital	Class 1	880.5820	2025-11-20
IQQ	Joint, Shoulder, External Limb Component	Physical Medicine	Class 1	890.3420	2025-11-20
IPX	Orthosis, Rib Fracture, Soft	Physical Medicine	Class 1	890.3490	2025-11-20
FYH	Splint, Extremity, Noninflatable, External, Sterile	General, Plastic Surgery	Class 1	878.3910	2025-11-20
HMP	Pad, Eye	General, Plastic Surgery	Class 1	878.4440	2025-11-20
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2025-11-20
KFT	Assembly, Shoulder/Elbow/Forearm/Wrist/Hand, Mechanical	Physical Medicine	Class 1	890.3420	2025-11-20
BTK	Strap, Head, Gas Mask	Anesthesiology	Class 1	868.5560	2025-11-20
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2025-11-20
OTX	Foot Wrap For Treating Restless Leg Syndrome Symptoms	Physical Medicine	Class 1	890.5760	2025-11-20
KBN	Gag, Mouth	Ear, Nose, Throat	Class 1	874.4420	2025-11-20
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2025-11-20

Official Correspondent

jianwen fei

US Agent Details

Paul Li Email: lisa@zxwy-md.com Phone: (312) 9856751

Related Public Records

Same Entity

GUARDMED HEALTHCARE KH 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
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31
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-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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1629057	WINFIELD LABORATORIES, INC.	Richardson, TX, US
3021695082	BEONE CO., LTD.	Gimpo Gyeonggi, KR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042251637. Last updated year: 2026. Please use registration number 3042251637 when referencing this establishment in official correspondence.