Identity
- Trade Name
- NEUWAVE ABLATE-IQ EUDAMED
- Device Name
- NEUWAVE ABLATE-IQ EUDAMED
- Model / Reference
- AIQP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10818913020742 EUDAMED
- Basic UDI-DI
- 081891302a0027F EUDAMED
- EMDN Code
- Z12010992 ELECTROSURGERY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Special Device Type
- Software 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 Ablate-Iq by NeuWave Medical, Inc. — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K232227 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 081891302a0027F | 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 (2)
- EUDAMED 353d03d1-2708-460c-a1c3-4bb7774cdb7d 61 fields · synced Oct 7, 2026
- FDA 510(k) K232227 1 fields · synced May 18, 2026