Identity
- Trade Name
- NRG™ EUDAMED
- Device Name
- NRG RF Transseptal Kit EUDAMED
- Model / Reference
- NTK3009 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00685447018759 EUDAMED
- Basic UDI-DI
- 06854470013PT EUDAMED
- EMDN Code
- C019015 CARDIAC TRANSSEPTAL PUNCTURE KITS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Medical Purpose
- The NRG RF Transseptal Kit offers the individually packaged NRG Transseptal Needle and TorFlex Transseptal Guiding Sheath in one single shipping box for the convenience of the user. This procedure pack provides the customer with all the devices required for transseptal access during the cardiovascular therapy procedures requiring introduction of various types of cardiovascular catheters and guidewires to all heart chambers. EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Nrg™ 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 | 06854470013PT | Class III | Active |
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Manufacturer
- Manufacturer
- Baylis Medical Company Inc.
- EUDAMED SRN
- CA-PR-000047675
Sources (1)
- EUDAMED 4460fddd-092c-40de-b96c-f707c35b163b 61 fields · synced Jul 15, 2026