Identity
- Trade Name
- NEUWAVE EUDAMEDFDA UDI
- Generic Name
- Microwave ablation system generator FDA UDI
- Device Name
- NEUWAVE Microwave Ablation System EUDAMEDNW Ablation System, US FDA UDI
- Model / Reference
- NWC1US1N EUDAMEDFDA UDI
- Description
- NW Ablation System, US FDA UDI
Identifiers
- Catalog Number
- NWC1US1N FDA UDI
- Primary DI / UDI-DI
- 00853719006753 EUDAMEDFDA UDI
- Basic UDI-DI
- 081891302a0017D EUDAMED
- Direct Marketing DI
- 00853719006753 EUDAMED
- FDA Product Code
- NEY FDA UDI
- EMDN Code
- Z12010902 ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE EUDAMED
- GMDN Term
- Microwave ablation system generator FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Foot-switch, electrical
Neuwave by NeuWave Medical, Inc. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081891302a0017D | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- NeuWave Medical, Inc.
- EUDAMED SRN
- US-MF-000016783
- Authorised Representative
- Johnson & Johnson Medical GmbH DE-AR-000007712
Sources (2)
- EUDAMED bfec2931-0bca-4888-a4bd-6875d0129a23 61 fields · synced Jun 8, 2026
- FDA UDI 4acc5455-1160-4cad-b503-77eb1c4d796d 36 fields · synced May 30, 2026