V3BIO SDN. BHD.

FDA Device Registration & Listing · Penang Pulau Pinang, MY · Registration 3026399481

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3026399481
FEI Number
3026399481
Entity Name
V3BIO SDN. BHD.
City/State/Country
Penang Pulau Pinang, MY
Establishment Address
No.. 18 Jalan Cassia Selatan 3.1, Taman Peridustrian Batu Kawan, 14100, Bandar Cassia, Penang Pulau Pinang 14100, MY
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
V3Bio Sdn. Bhd. (Owner Number: 10087235)
Owner / Operator Contact Address
Np. 18 Jalan Cassia Selatan, Taman Peridustrian Batu Kawan, 14100, Bandar Cassia, Penang, MY-NOTA 75502, MY
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K220286
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FRO Dressing, Wound, Drug Unknown Class U N/A 2023-01-31

Official Correspondent

Miriam Walls

US Agent Details

Miriam Walls Business: xFDA, Inc Email: mwalls@xfda.com Phone: (703) 9195372

Related Public Records

Same Entity

V3Bio Sdn. Bhd.
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
K150256 Argentum Medical SILVERLON BURN CONTACT DRESSINGS 2015-04-30

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0003-06 B. Braun Medical, Inc. U
D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025 3M Company Health Care Business 3m Center U
3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026399481. Last updated year: 2026. Please use registration number 3026399481 when referencing this establishment in official correspondence.
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