Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012706495

FEI Number

3012706495

Entity Name

HENSO MEDICAL (HANGZHOU) CO.,LTD.

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

1-510 Tongpu Road, Hangzhou Zhejiang 310012, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Henso Medical (Hangzhou) Co.,Ltd. (Owner Number: 10057010)

Owner / Operator Contact Address

1-510 Tongpu Road, Hangzhou, CN-ZJ 310012, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Urine Cup, Stool Container, Sputum Container Kinesiology tape, Sport Tapes, Adhesive Tape and Bandage Microneedle Patch, Pimple Patch Anti-leakage strip; Hydrocolloid skin barrier; Hydrocolloid skin protective ring; Protective dressing wipe; Skin protect Urinary Test Non-Quant., PH Urinalysis Reagent Test Strips, UTI test strips Elastic Bandage, Crepe Bandage, Tubular Bandage, PBT Bandage, Cohesive Elastic Bandage, Elastic Adhesive Bandage Light Handle Cover Hydrogel Dressing, Cooling Gel Sheet Foam Dressing, Hydrocolloid Dressing, Hydrocolloid Foam Dressing, Nonwoven wound dressing NPWT Dressing, Silicone Dressing, Super Absorbency Dressing SWABS Ostomy Bags Petri Dishes, Culture Plate, Deep Well Plate Silicone Gel Scar Sheet Acne Patch; Alginate Dressing

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2018-02-08
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2018-02-08
EXE	Protector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2019-05-26
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2018-02-08
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2018-02-08
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2018-02-08
FTA	Light, Surgical, Accessories	General, Plastic Surgery	Class 2	878.4580	2019-05-26
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2018-02-08
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2018-02-08
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2020-06-17
FON	Bag, Drainage, With Adhesive, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2018-02-08
KIZ	Dish, Tissue Culture	Hematology	Class 1	864.2240	2018-04-23
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2019-05-26
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2018-02-08

Official Correspondent

Sheng Wang

US Agent Details

Hui Hong Email: info@abmed.us Phone: (303) 8000162

Related Public Records

Same Entity

Henso Medical (Hangzhou) 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
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
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31

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 3012706495. Last updated year: 2026. Please use registration number 3012706495 when referencing this establishment in official correspondence.