gudid
Primary ID: 3cm4cm
OPTITEKNIK (UDI 3cm4cm)
Manufactured by Roosin Medical Co., Ltd.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for OPTITEKNIK - Primary ID 3cm4cm
Device Regulatory Overview
The OPTITEKNIK (Model/Catalog Number: 3cm4cm) is a medical device manufactured by Roosin Medical Co., Ltd.. This product is indexed under FDA Product Code / Category Classification FRO within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 3cm4cm
- Product Code / EMDN
- FRO
- Device Name
- Polyver Silver Alginate Dressing 3cm4cm
- Database Sync Date
- 2026-08-09 09:21:59
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of OPTITEKNIK?
The registered manufacturer of record for OPTITEKNIK is Roosin Medical Co., Ltd..
What is the Primary UDI-DI identifier for OPTITEKNIK?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 3cm4cm.
What classification code is assigned to this device?
This device is registered under product classification code FRO.
Similar Classification Devices (FRO)
Other Devices by Roosin Medical Co., Ltd.
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