Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011715978

FEI Number

3011715978

Entity Name

SUZHOU HAODY MEDICAL PRODUCTS CO. LTD.

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

19 Shengtai Road, Beiqiao Town, Xiangcheng District, Suzhou Jiangsu 2150000, CN

Establishment Type(s)

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

Owner / Operator

Suzhou Haody Medical Products Co. Ltd. (Owner Number: 10062053)

Owner / Operator Contact Address

19 Shengtai Road, Beiqiao Town, Xiangcheng District, Suzhou, CN-JS 2150000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Non-adhesive Dressing PBT Bandage Non-woven Swabs isolation gown

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2019-12-13
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2020-12-21
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2020-12-21
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2020-12-21
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-04-01

Official Correspondent

No official correspondent registered.

US Agent Details

Rosanna Lee Business: Simcon International LLC Email: rlee@simconintl.com Phone: (847) 9492290

Related Public Records

Same Entity

Suzhou Haody Medical Products 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

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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3011280379	DONGGUAN CITY RISEN MEDICAL PRODUCTS CO., LTD	Dongguan Guangdong, CN
3003767891	PHARMAPLAST S.A.E.	ALEXANDRIA Al Iskandariyah, EG
3030691709	NextBeam	North Sioux City, SD, US
1043542	BRECON KNITTING MILL, INC.	Talladega, AL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011715978. Last updated year: 2026. Please use registration number 3011715978 when referencing this establishment in official correspondence.