Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013530949

FEI Number

3013530949

Entity Name

Wenzhou Celecare Medical lnstruments Co.,Ltd.

City/State/Country

wenzhou Zhejiang, CN

Establishment Address

NO.407 XIAJIN RD(1-4th Floor),JINZHU INDUSTRIAL ZONE, NANBAIXIANG STREET,OUHAI DISTRICT, wenzhou Zhejiang 325000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Wenzhou Celecare Medical lnstruments Co.,Ltd. (Owner Number: 10053640)

Owner / Operator Contact Address

NO.407 XIAJIN RD(1-4th Floor),JINZHU INDUSTRIAL ZONE, NANBAIXIANG STREET,OUHAI DISTRICT, WENZHOU, CN-ZJ 325000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ostomy Care Accessories;Colostomy Bag;Ostomy Bag Ostomy Plug Ostomy Baseplate Phototherapy Diaper;BiliTouch Eye Protection M/L Eye mask Neonatal phototherapy eye mask Transparent Dressing Protective Suit(Protective Coverall Safety Suit) Urine Bag; Water Proof Bag; Dry Bag Urostomy Bag Adult Incontinence Kit With Urine Collection Bag Catheter Eye Patch Facial mask Silicone Dressing;Silicone Gel;Scar Patch;Nicotine Patch/Stop Smoking Aid;Nose Patch Lip Patch Face Mask Anaesthetic mask Respiratory mask

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EZQ	Pouch, Colostomy	Gastroenterology, Urology	Class 1	876.5900	2016-12-26
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2016-12-26
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2016-12-26
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-03-13
EXG	Bag, Urine Collecting, Ureterostomy	Gastroenterology, Urology	Class 1	876.5900	2016-12-26
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2016-12-26
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-13
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2023-12-13

Official Correspondent

Shengwu Zheng

US Agent Details

Li Du Email: duli77077@outlook.com Phone: (405) 4320577

Related Public Records

Same Entity

Wenzhou Celecare Medical lnstruments 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
3006709396	AMPARO MEDICAL TECHNOLOGIES, INC.	Anaheim, CA, US
3019865496	Dongguan Kangda Medical Technology Co., Ltd	Dongguan Guangdong, CN
9617198	SALTS HEALTHCARE LIMITED	ASTON BIRMINGHAM, GB
3008806809	ConvaTec Limited, GDC Building	Deeside Flintshire, GB
3020978007	DONGGUAN BAO KANG DIAN ZI KE JI LIMITED	Dongguan City Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013530949. Last updated year: 2026. Please use registration number 3013530949 when referencing this establishment in official correspondence.