Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3025430795

FEI Number

3025430795

Entity Name

BLUEMED HEALTHCARE CO.,LTD

City/State/Country

Shanghai, CN

Establishment Address

Area C, 3rd Floor, No 5 building, Lane 255 Dongyu Road, Shanghai 201419, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

BLUEMED HEALTHCARE CO.,LTD (Owner Number: 10086522)

Owner / Operator Contact Address

Area C, 3rd Floor, No 5 building, Lane 255 Dongyu Road, Shanghai, CN-NOTA 201419, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

hydrocolloid dressing, hydrogel dressing Ostomy bag ADHESIVE TAPE sterilized gauze, burn care dressing wound plaster, alginate dressing, non woven dressing, foam dressing, acne patch Pepper Capsicum Adhesive Plaster, Cooling patch Film dressing, Blister plaster gauze swab, lap sponge, paraffin gauze, sterilized lap sponge, Non woven swab, Sterilized non woven swab Corn plaster elastic bandage

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2022-11-15
FON	Bag, Drainage, With Adhesive, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2024-02-26
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2022-11-15
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2022-11-15
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2022-11-15
OMW	Adhesive Backed Thermal Skin Patches	Physical Medicine	Class 1	890.5710	2022-11-15
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2022-11-15
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2022-11-15
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2023-11-26
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2022-11-15

Official Correspondent

JIE QI

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

BLUEMED HEALTHCARE 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.

Similar Registrations

Registration Number	Establishment Name	Location
3009662219	Custom Medical and Safety Products Inc.	Buffalo, NY, US
3038014307	CURAPEP LLC	Burlington, WI, US
3043012215	ZENESIS HOLDINGS CO., LIMITED	Kowloon, HK
3008646686	KIKGEL	Ujazd Opolskie, PL
8043484	Smith & Nephew Medical Ltd	HULL East Riding of Yorkshire, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3025430795. Last updated year: 2026. Please use registration number 3025430795 when referencing this establishment in official correspondence.