Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3025430561

FEI Number

3025430561

Entity Name

CHENGDU RUINUO MEIJER MEDICAL INSTRUMENT CO., LTD.

City/State/Country

Chengdu Sichuan, CN

Establishment Address

Chengdu Tianfu International Bio-town (No. 269, Fenghuang Road, Shuangliu District), Chengdu Sichuan 610200, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Chengdu Ruinuo Meijer Medical Instrument Co., Ltd. (Owner Number: 10086531)

Owner / Operator Contact Address

Chengdu Tianfu International Bio-town (No. 269, Fenghuang Road, Shuangliu District), Chengdu, CN-SC 610200, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Elastomer, silicone, for scar management Gown, examination TOURNIQUET, NONPNEUMATIC TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, MANUAL BANDAGE, CAST Pack, hot or cold, water circulating MJ-4 MJ- III Dressing, wound, occlusive Non-surgical gown Splint, extremity, non-inflatable, external, non-sterile Dressing, wound, hydrophilic Pack, hot or cold, reusable

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2022-11-16
FME	Gown, Examination	General Hospital	Class 1	880.6265	2022-11-16
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2022-11-16
JEB	Table, Surgical With Orthopedic Accessories, Manual	General, Plastic Surgery	Class 1	878.4950	2022-11-16
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2022-11-16
ILO	Pack, Hot Or Cold, Water Circulating	Physical Medicine	Class 2	890.5720	2022-11-16
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2022-11-16
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2022-11-16
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2022-11-16
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2022-11-16
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2022-11-16

Official Correspondent

Ke Zhang

US Agent Details

hui hong Business: ABMED MEDICAL TECHNOLOGY INC Email: info@abmed.us Phone: (509) 5816099

Related Public Records

Same Entity

Chengdu Ruinuo Meijer Medical Instrument 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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3025430561. Last updated year: 2026. Please use registration number 3025430561 when referencing this establishment in official correspondence.