gudid
Primary ID: 4
CER-S (UDI 4)
Manufactured by CARDIO CALM SRL
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for CER-S - Primary ID 4
Device Regulatory Overview
The CER-S (Model/Catalog Number: 4) is a medical device manufactured by CARDIO CALM SRL. This product is indexed under FDA Product Code / Category Classification DQK within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 4
- Product Code / EMDN
- DQK
- Device Name
- CER-S is stand-alone software medical device, providing advanced solutions for importing, analyzing, editing, reviewing and generating clinical reports related to digital continuous ECG recordings (Holters). CER-S does not carry out an automated interpretation of the ECG data.
- Database Sync Date
- 2026-08-09 09:06:20
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 CER-S?
The registered manufacturer of record for CER-S is CARDIO CALM SRL.
What is the Primary UDI-DI identifier for CER-S?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 4.
What classification code is assigned to this device?
This device is registered under product classification code DQK.
Similar Classification Devices (DQK)
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