Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007307589

FEI Number

3007307589

Entity Name

RFX+CARE MANUFACTURING CO., LTD.

City/State/Country

Shaoxing Zhejiang, CN

Establishment Address

No.599-1F Wuxie Road, Yuecheng District, Shaoxing Zhejiang 312000, CN

Establishment Type(s)

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

Owner / Operator

RFX+CARE Manufacturing Co., Ltd. (Owner Number: 10027255)

Owner / Operator Contact Address

No.599-1F Wuxie Road, Yuecheng District, Shaoxing, CN-ZJ 312000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Hydrocolloid Dressing After Bites Blister Plaster Spot Patch Acne Patch Insect Bites Patch Pimple Patch Blemish Patch m. Dior Face mask Vinyl Patient Examination Glove-Disposable Gloves Disposable Gloves Vinyl Patient Examination Gloves Examination Gloves RFX+CARE Plaster, adhesive tape Barbie Collection Water-Proof Adhesive Bandages Set Bee plaster Burn kit Emergency blanket RFX+CARE Body warmer Ice pack RFX+CARE Toothbrush RFX+CARE RFX+CARE Burn gel dressing Burn gel RFX+CARE Forehead thermometer surgical face mask RFX+CARE Elastic bandage

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2016-08-05
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2022-12-08
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2020-07-30
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2020-08-11
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2013-01-09
OJI	Burn Kit With Drug	Unknown	Class N	N/A	2025-05-30
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2016-08-05
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2015-09-23
LRR	First Aid Kit With Drug	Unknown	Class N	N/A	2016-12-19
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2013-01-09
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2015-09-23
KPD	Strip, Temperature, Forehead, Liquid Crystal	General Hospital	Class 2	880.2200	2015-10-18
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-06-07
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2015-10-18

Official Correspondent

No official correspondent registered.

US Agent Details

Kevin Walls Business: Regulatory Insight, Inc. Email: kevin@reginsight.com Phone: (720) 9625412

Related Public Records

Same Entity

RFX+CARE Manufacturing 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
K052612	Shanghai Antares Industries, Inc.	DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN BLUE COLOR	2005-11-22
K120584	Wealth on (Jiangsu) Co., Ltd.	POWER FREE STRETCH VINYL PATIENT EXAMINATION GLOVES	2012-07-10
K220992	Ever Global (Vietnam) Enterprise Corporation	Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple	2022-10-19
K112610	Inpro Technology Device Factory	SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS)	2011-12-05

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 3007307589. Last updated year: 2026. Please use registration number 3007307589 when referencing this establishment in official correspondence.