Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3029995180

FEI Number

3029995180

Entity Name

SHANDONG SHINRISE MEDICAL SUPPLIES CO., LTD

City/State/Country

Zibo Shandong, CN

Establishment Address

No.56 Zhangbei Road,Guoli Town,Huantai County, Zibo Shandong 256410, CN

Establishment Type(s)

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

Owner / Operator

Shandong Shinrise Medical Supplies Co., LTD (Owner Number: 10088900)

Owner / Operator Contact Address

No.56 Zhangbei Road,Guoli Town,Huantai County, Zibo, CN-ZJ 256410, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Incise Drape Surgical Incise film Foam Dressing Transparent Wound Dressing Silicone Non Woven Wound Dressing Non Adherent Wound Dressing Pad Adhesive Wound Dressing NPWT Dressing Kit Silicone Foam Dressing Silicone Transparent Wound Dressing Hydrocolloid Dressing Alginate Dressing Cannular Fixation Device I.V. Fixation Dressing Silicone Wound Contact Dressing Transparent Film Dressing

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2023-10-19
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2023-10-19
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2023-10-19
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2023-10-19

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: David.Lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Shandong Shinrise Medical Supplies 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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3043535425	K-ONE MEDITECH SDN. BHD.	Sekinchan Selangor, MY
3012508471	P3 MEDICAL LTD	Bristol Bristol, City of, GB
3004133257	AMMAR APPAREL II S. DE R.L DE C.V.	CALKINI Campeche, MX
3010202439	Karl Storz Endoscopy-America, Inc.	El Segundo, CA, US
3019798849	EXCELLENT MEDICAL TECHNOLOGY (THAILAND) CO., LTD.	U-Thai District Phra Nakhon Si Ayutthaya, TH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3029995180. Last updated year: 2026. Please use registration number 3029995180 when referencing this establishment in official correspondence.