Identity
- Trade Name
- VersaCross Connect™ EUDAMED
- Device Name
- VersaCross Connect Access Solution EUDAMED
- Model / Reference
- VXAK3003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00685447016571 EUDAMED
- Basic UDI-DI
- 06854470026Q4 EUDAMED
- EMDN Code
- C019015 CARDIAC TRANSSEPTAL PUNCTURE KITS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Medical Purpose
- The VersaCross Connect Access Solution Procedure Packs provide the VersaCross RF Wire and compatible connector cable with compatible VersaCross Connect Transseptal Dilator in a single sterile barrier. These solutions provide the customer with all the devices required for transseptal access during the cardiovascular therapy procedures requiring the introduction of various types of cardiovascular catheters and guidewires to all heart chambers within a single sterile barrier. EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
VersaCross Connect™ by Baylis Medical Company Inc. — Class III — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 06854470026Q4 | Class III | Active |
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Manufacturer
- Manufacturer
- Baylis Medical Company Inc.
- EUDAMED SRN
- CA-PR-000047675
Sources (1)
- EUDAMED 8eccc35e-f0af-4d0b-a699-f50def2f5865 61 fields · synced May 23, 2026