Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010805190

FEI Number

3010805190

Entity Name

CHANGZHOU RECOO HEALTHCARE CO., LTD.

City/State/Country

Changzhou Jiangsu, CN

Establishment Address

402 No3 BLD ZHIYAN Valley BOJI Industrial Zone Zouqu Town Zhonglou, Changzhou Jiangsu 213000, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Changzhou Recoo Healthcare Co., Ltd. (Owner Number: 10046329)

Owner / Operator Contact Address

402 No3 BLD ZHIYAN Valley BOJI Industrial Zone Zouqu Town Zhonglou, Changzhou, CN-JS 213000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Hot and cold pack Sterile hydrocolloid dressing, FOOT BLISTER PAD /FOOT CUSHION, ACNE PATCH/PIMPLE PATCH Under pad Ice Pack Nasal Strip Identification Band Medical Face Mask First aid kit without drug Tourniquet Latex bandage, Elastic bandage Wound dressing series Silicone Scar Tape, SILICONE TAPE/SILICONE SCAR SHEET Oxygen mask Nebulizer mask Ear Plug Kinesiology Tape Foam Tape Sports Tape Alcohol pad

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2015-12-17
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2020-10-23
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2015-12-17
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2015-12-17
LWF	Dilator, Nasal	Ear, Nose, Throat	Class 1	874.3900	2023-11-07
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2019-12-05
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	2020-06-28
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2017-11-06
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2024-10-21
FQA	Scale, Surgical Sponge	General Hospital	Class 1	880.2740	2024-10-21
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2021-10-24
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2022-08-15
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2015-12-17
EWD	Protector, Hearing (Insert)	Unknown	Class U	N/A	2023-11-07
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2014-03-06
LKB	Pad, Alcohol, Device Disinfectant	Unknown	Class U	N/A	2016-07-09

Official Correspondent

Sherlock Zhou

US Agent Details

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

Related Public Records

Same Entity

Changzhou Recoo 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
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
3037007193	SHANGHAI HUIZHOU INDUSTRIAL CO., LTD	Shanghai City District, CN
3031182683	NINGBO YAMAI INDUSTRY AND TRADE CO., LTD.	Yuyao Zhejiang, CN
3016711531	BRANCH IN PHU THO, THYGESEN TEXTILE VIETNAM COMPANY LIMITED	Yen Lap Commune Phu Tho, VN
3008384548	ACTIVE-ICE, INC.	Norman, OK, US
3002393819	MEDICAL SPECIALTIES OF CALIFORNIA LIMITED	Orpington Kent, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010805190. Last updated year: 2026. Please use registration number 3010805190 when referencing this establishment in official correspondence.