Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010957766

FEI Number

3010957766

Entity Name

Wenzhou Scico Medical Corporation Co.,Ltd.

City/State/Country

Longgang, Wenzhou Zhejiang, CN

Establishment Address

Floors 1, 4 & 5, Building 1,, No. 14, Lane 699, Shiji Avenue, Longgang, Wenzhou Zhejiang 325802, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Wenzhou Scico Medical Corporation Co.,Ltd. (Owner Number: 10046880)

Owner / Operator Contact Address

Floors 1, 4 & 5, Building 1,, No. 14, Lane 699, Shiji Avenue, Longgang City Wenzhou, CN-ZJ 325802, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Hydrogel wound dressing and burn dressing Gauze/Sponge, Nonresorable for External Use Fixing Dressing; Transparent Dressing Dressing,Wound,Occlusive Bandage, Cold Bandage, Elastic Self-adhesive, Elastic Bandage Dog Bandages Cold Bandage Wenzhou Scico Medical Plaster of Paris Pet Cast Immobilizer Bandage, Cast Cotton Roll Cotton Swabs

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	2025-12-10
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2024-11-12
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2025-12-10
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2014-05-25
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2020-05-28
EFN	Cotton, Roll	Dental	Class 1	872.6050	2017-12-21

Official Correspondent

No official correspondent registered.

US Agent Details

william slevin Business: medapproval llc Email: qara@medapprovalllc.com Phone: (404) 5935005

Related Public Records

Same Entity

Wenzhou Scico Medical Corporation 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

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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 3010957766. Last updated year: 2026. Please use registration number 3010957766 when referencing this establishment in official correspondence.