Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011814545

FEI Number

3011814545

Entity Name

WUHAN SITAILI MEDICAL APPARATUS DEVELOPMENT CO.,LTD

City/State/Country

Wuhan Hubei, CN

Establishment Address

7th Floor, 7th building Guannan Fuxing Medical Industrial Park, No. 62 Guanggu Road, East Lake New Technology Development Zone, Wuhan Hubei 430074, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Wuhan Sitaili Medical Apparatus Development Co.,Ltd (Owner Number: 10057778)

Owner / Operator Contact Address

7th Floor, 7th building Guannan Fuxing Medical Industrial Park, No. 62 Guanggu Road, East Lake New Technology Development Zone, Wuhan, CN-HB 430074, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

medical adhesive tape Ostomy remover spray ostomy elastic tape, Ostomy belt, Skin barrier spray, Ostomy scissors) Ostomy remover wipes, Deodorant Lubricant, Ostomy belt, Ostomy abdominal belt, Ostomy Viscosifie, Ostomy Filter ostomy accessories (ostomy paste, ostomy mouldable ring, ostomy strip ostomy skin protective film, ostomy powder, Hydrocolloid dressing Medical tape Isolation gown Urinary Leg Bag Healing bandage ostomy bag

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2021-11-08
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2021-11-08
EXE	Protector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2018-05-24
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2024-10-29
PYO	Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use	General Hospital	Class 1	880.5240	2023-01-03
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2021-11-08
FAQ	Bag, Urine Collection, Leg, For External Use, Sterile	Gastroenterology, Urology	Class 1	876.5250	2026-05-05
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2023-01-03
FON	Bag, Drainage, With Adhesive, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2018-05-24

Official Correspondent

Isabel Liu

US Agent Details

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

Related Public Records

Same Entity

Wuhan Sitaili Medical Apparatus Development 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
K791969	Medline Industries, Inc.	DYNACOR STERILE CLOSED SYS. DRAINAGE BAG	1979-11-05

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3012453673	FANNIN (UK) LIMITED	Measham, Swadlincote Derbyshire, GB
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011814545. Last updated year: 2026. Please use registration number 3011814545 when referencing this establishment in official correspondence.