gudid
Primary ID: SP1
Ergofilter (UDI SP1)
Manufactured by FIM MEDICAL
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Ergofilter - Primary ID SP1
Device Regulatory Overview
The Ergofilter (Model/Catalog Number: SP1) is a medical device manufactured by FIM MEDICAL. This product is indexed under FDA Product Code / Category Classification BZG within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- SP1
- Product Code / EMDN
- BZG
- Device Name
- accessory to active diagnostic devices: FIM Spirometers
- Database Sync Date
- 2026-08-09 09:33:50
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 Ergofilter?
The registered manufacturer of record for Ergofilter is FIM MEDICAL.
What is the Primary UDI-DI identifier for Ergofilter?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is SP1.
What classification code is assigned to this device?
This device is registered under product classification code BZG.
Similar Classification Devices (BZG)
Other Devices by FIM MEDICAL
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