gudid
Primary ID: FFD-200A
STROMATOLYSER-4DL (UDI FFD-200A)
Manufactured by SYSMEX CORPORATION
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for STROMATOLYSER-4DL - Primary ID FFD-200A
Device Regulatory Overview
The STROMATOLYSER-4DL (Model/Catalog Number: FFD-200A) is a medical device manufactured by SYSMEX CORPORATION. This product is indexed under FDA Product Code / Category Classification GGK within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- FFD-200A
- Product Code / EMDN
- GGK
- Device Name
- Lysing reagent for hematology analyzers
- Database Sync Date
- 2026-08-09 09:17:27
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 STROMATOLYSER-4DL?
The registered manufacturer of record for STROMATOLYSER-4DL is SYSMEX CORPORATION.
What is the Primary UDI-DI identifier for STROMATOLYSER-4DL?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is FFD-200A.
What classification code is assigned to this device?
This device is registered under product classification code GGK.
Similar Classification Devices (GGK)
Other Devices by SYSMEX CORPORATION
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