BIOPAD

GUDID 08054953400105

BIOPAD® is a wound dressing for topical use to control minor bleedings and for the management of any kind of ulcer and skin lesion to help wound closure. BIOPAD® is a sponge-shaped device, constituted exclusively by lyophilized type I native heterologous collagen extracted from horse flexor tendon. When applied to a wound, BIOPAD® constitutes a barrier for the wound against exogenous infective agents. BIOPAD® is the ideal first-aid means to control minor bleeding. The device may be used by healthcare professionals. BIOPAD® is supplied sterile and for one-time use only.

EURORESEARCH SRL

Animal-derived wound matrix dressing

• Primary Device ID: 08054953400105
• NIH Device Record Key: 9a697d16-2273-4124-a12c-33bcd40703fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOPAD
• Version Model Number: 2x2
• Company DUNS: 429605488
• Company Name: EURORESEARCH SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08054953400105 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040283

FDA Product Code

• FRO: Dressing, Wound, Drug

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-07-21
• Device Publish Date: 2022-12-28

On-Brand Devices [BIOPAD]

• 08054953400112: BIOPAD® is a wound dressing for topical use to control minor bleedings and for the management o
• 08054953400105: BIOPAD® is a wound dressing for topical use to control minor bleedings and for the management o