Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009548473

FEI Number

3009548473

Entity Name

YAFHO BIO-TECHNOLOGY CO., LTD.

City/State/Country

GUANGZHOU Guangdong, CN

Establishment Address

RM 202,2nd & 3RD Floor, JUNFENG RD NO.81,HUANGPU DISTRICT,GUANGZHOU, GUANGZHOU Guangdong 510760, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Yafho Bio-Technology Co., Ltd. (Owner Number: 10090388)

Owner / Operator Contact Address

RM 202,2nd & 3RD Floor, JUNFENG RD NO.81,HUANGPU DISTRICT,GUANGZHOU, GUANGZHOU, CN-GD 510760, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Wound Closure System Sterile Instrument Cover Wound Closure Strips I.V. Start Kit Hydrogel Dressing I.V. Fixation Dressing Catheter Securement Device Silicone Foam Dressing Silicone Wound Contact layer Foam Dressing Tracheostomy Tube Holder Surgical Tape Island Film Dressing Island Non-woven Dressing Tracheal Compress Dressing Hydrofiber Foam Dressing Alginate Dressing Calcium Alginate Dressing Hydrofibe Dressing Non-adherent Dressing Pad

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FZW	Expander, Surgical, Skin Graft	General, Plastic Surgery	Class 1	878.4800	2024-03-21
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2024-03-21
FPX	Strip, Adhesive, Closure, Skin	General Hospital	Class 1	880.5240	2024-03-21
LRS	I.V. Start Kit	General Hospital	Class 2	880.5200	2024-03-21
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2024-03-21
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2024-03-21
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2024-03-21
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	2024-03-21
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2024-03-21
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2024-03-21
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2024-03-21

Official Correspondent

Miner Qin

US Agent Details

hui hong Business: ABMED MEDICAL TECHNOLOGY INC Email: info@abmed.us Phone: (303) 8000162

Related Public Records

Same Entity

Yafho Bio-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
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009548473. Last updated year: 2026. Please use registration number 3009548473 when referencing this establishment in official correspondence.