Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3035523371

FEI Number

3035523371

Entity Name

PT. JAYAMAS WELLONG MEDICAL

City/State/Country

Kab. Jombang Jawa Timur, ID

Establishment Address

Dusun Karangmenjangan, Desa Karangwinongan Kec. Mojoagung, Kab. Jombang Jawa Timur 61482, ID

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

PT. Jayamas Wellong Medical (Owner Number: 10092413)

Owner / Operator Contact Address

Dusun Karangmenjangan, Desa Karangwinongan Kec. Mojoagung, Kab. Jombang, ID-JI 61482, ID

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Welling Incise Drape Wellong Gauze and Sponge Wellong Medical Wedges Wellong Medical Boots Wellong Hydrophilic Dressing

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FYE	Dress, Surgical	General, Plastic Surgery	Class 1	878.4040	2025-02-26
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2025-02-26
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2025-01-03
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2025-02-26

Official Correspondent

William Slevin

US Agent Details

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

Related Public Records

Same Entity

PT. Jayamas Wellong Medical

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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3010864832	3D DENTAL DESINGS AND DEVELOPMENT	Shaker Heights, OH, US
3005012805	MIDWEST STERILIZATION CORP.	LAREDO, TX, US
3033511100	JINGXIN GROUP (M) SDN BHD	Kulai Johor, MY

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3035523371. Last updated year: 2026. Please use registration number 3035523371 when referencing this establishment in official correspondence.