gudid
Primary ID: PACE 203
CARDIOTRONIC (UDI PACE 203)
Manufactured by Osypka Medical GmbH
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for CARDIOTRONIC - Primary ID PACE 203
Device Regulatory Overview
The CARDIOTRONIC (Model/Catalog Number: PACE 203) is a medical device manufactured by Osypka Medical GmbH. This product is indexed under FDA Product Code / Category Classification DTE within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- PACE 203
- Product Code / EMDN
- DTE
- Device Name
- PACE 203 External Dual-Chamber Pacemaker (with clamping terminals)
- Database Sync Date
- 2026-08-09 09:53:22
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 CARDIOTRONIC?
The registered manufacturer of record for CARDIOTRONIC is Osypka Medical GmbH.
What is the Primary UDI-DI identifier for CARDIOTRONIC?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is PACE 203.
What classification code is assigned to this device?
This device is registered under product classification code DTE.
Similar Classification Devices (DTE)
Other Devices by Osypka Medical GmbH
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