Identity
- Trade Name
- NEUWAVE EUDAMED
- Device Name
- NEUWAVE Microwave Ablation System EUDAMED
- Model / Reference
- NWC2IT1N EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00853719006654 EUDAMED
- Basic UDI-DI
- 081891302a0017D EUDAMED
- EMDN Code
- Z12010902 ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Belgium 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
Neuwave by NeuWave Medical, 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 | 081891302a0017D | Class IIb | Active |
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Manufacturer
- Manufacturer
- NeuWave Medical, Inc.
- EUDAMED SRN
- US-MF-000016783
- Authorised Representative
- Johnson & Johnson Medical GmbH DE-AR-000007712
Sources (1)
- EUDAMED 6c060084-e7c2-43f6-ae6e-0f3a9f74eae0 61 fields · synced Jun 8, 2026