Identity
- Trade Name
- HexaGen™ EUDAMED
- Device Name
- HexaGen RF Generator EUDAMED
- Model / Reference
- AFR-00004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00763000998318 EUDAMED
- Basic UDI-DI
- 0763000B000262488 EUDAMED
- EMDN Code
- Z120101 ARTERIOTOMY ABLATORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
HexaGen™ by Medtronic, Inc. — Class IIb — 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 | 0763000B000262488 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Medtronic, Inc.
- EUDAMED SRN
- US-MF-000019977
- Authorised Representative
- Medtronic B.V. NL-AR-000006050
Sources (1)
- EUDAMED e1cab5b9-fdd1-4398-8d8b-745e74b4184f 61 fields · synced Jun 18, 2026