eudamed_udi
Primary ID: 04968420514964
Surdial X (UDI 04968420514964)
Manufactured by NIPRO CORPORATION
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Surdial X - Primary ID 04968420514964
Device Regulatory Overview
The Surdial X (Model/Catalog Number: Type B 230V) is a medical device manufactured by NIPRO CORPORATION. This product is indexed under FDA Product Code / Category Classification Z12090201 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- Type B 230V
- Product Code / EMDN
- Z12090201
- Device Name
- Single Patient Dialysis Machine
- Database Sync Date
- 2026-08-09 17:22:39
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
Unlock Compliance Data & Serialization Specs
Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.
Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of Surdial X?
The registered manufacturer of record for Surdial X is NIPRO CORPORATION.
What is the Primary UDI-DI identifier for Surdial X?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 04968420514964.
What classification code is assigned to this device?
This device is registered under product classification code Z12090201.
Similar Classification Devices (Z12090201)
Other Devices by NIPRO CORPORATION
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint