GUDIDData
eudamed_udi Primary ID: 08885013953046

Sentosa SA C. diff PCR Test v2.0 (4x24) (UDI 08885013953046)

Manufactured by Vela Operations Singapore Pte. Ltd.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Sentosa SA C. diff PCR Test v2.0 (4x24) - Primary ID 08885013953046

Device Regulatory Overview

The Sentosa SA C. diff PCR Test v2.0 (4x24) (Model/Catalog Number: 3000249) is a medical device manufactured by Vela Operations Singapore Pte. Ltd.. This product is indexed under FDA Product Code / Category Classification W0105011804 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
3000249
Product Code / EMDN
W0105011804
Device Name
Sentosa SA C. diff PCR Test v2.0 (4x24)
Database Sync Date
2026-08-09 18:10:57

Full Regulatory Attributes

🔒 Token Gated
{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}
                            

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Frequently Asked Questions

Who is the primary manufacturer of Sentosa SA C. diff PCR Test v2.0 (4x24)?

The registered manufacturer of record for Sentosa SA C. diff PCR Test v2.0 (4x24) is Vela Operations Singapore Pte. Ltd..

What is the Primary UDI-DI identifier for Sentosa SA C. diff PCR Test v2.0 (4x24)?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 08885013953046.

What classification code is assigned to this device?

This device is registered under product classification code W0105011804.

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