Identity
- Trade Name
- NEUWAVE EUDAMEDFDA UDI
- Generic Name
- Microwave ablation system generator FDA UDI
- Device Name
- NEUWAVE Footswitches EUDAMEDFootswitch Standard USB FDA UDI
- Model / Reference
- FSWITCH1 EUDAMEDFDA UDI
- Description
- Footswitch Standard USB FDA UDI
Identifiers
- Catalog Number
- FSWITCH1 FDA UDI
- Primary DI / UDI-DI
- 00853719006500 EUDAMEDFDA UDI
- Basic UDI-DI
- 081891302a0057M EUDAMED
- Direct Marketing DI
- 00853719006500 EUDAMED
- FDA Product Code
- NEY FDA UDI
- EMDN Code
- Z12010980 ELECTROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Microwave ablation system generator FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Belgium EUDAMED
- 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
Neuwave by NeuWave Medical, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 081891302a0057M | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 9a424836-401a-4c96-9e44-680eca0fb5d5 61 fields · synced Jun 8, 2026
- FDA UDI b02125c5-f5dc-4b14-a2a0-b2d18f9ea4cb 36 fields · synced May 27, 2026