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Neuwave

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref NWC2HK1NRef NWC2NL1NRef CTBKT3Ref NWC1BA2NRef NWSR25

by NeuWave Medical, Inc.

Identity

Trade Name
NEUWAVE EUDAMEDFDA UDI
Generic Name
Microwave ablation system probe, non-powered FDA UDI
Microwave ablation system generator FDA UDI
Device Name
NEUWAVE Microwave Ablation System EUDAMED
NEUWAVE Surgical PDM Mount, CT Bed Rail Mounts EUDAMED
NEUWAVE Ablation Probe EUDAMED
NEUWAVE SR Probe 25CM 13ga FDA UDI
CT Bed Rail Mount, Toshiba FDA UDI
Model / Reference
NWC2HK1N EUDAMED
NWC2NL1N EUDAMED
CTBKT3 EUDAMEDFDA UDI
NWC1BA2N EUDAMED
NWSR25 EUDAMEDFDA UDI
Description
NEUWAVE SR Probe 25CM 13ga FDA UDI
CT Bed Rail Mount, Toshiba FDA UDI

Identifiers

Catalog Number
NWSR25 FDA UDI
CTBKT3 FDA UDI
Primary DI / UDI-DI
00853719006647 EUDAMED
00853719006678 EUDAMED
00853719006470 EUDAMEDFDA UDI
00818913020653 EUDAMED
00853719006432 EUDAMEDFDA UDI
Basic UDI-DI
081891302a0017D EUDAMED
081891302a0047K EUDAMED
081891302a0037H EUDAMED
Direct Marketing DI
00853719006470 EUDAMED
FDA Product Code
NEY FDA UDI
BWN FDA UDI
EMDN Code
Z12010902 ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE EUDAMED
Z12010980 ELECTROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Z12010985 ELECTROSURGERY INSTRUMENTS - CONSUMABLES EUDAMED
GMDN Term
Microwave ablation system probe, non-powered FDA UDI
Microwave ablation system generator FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class I EUDAMEDFDA UDI
Class II FDA UDI
Regulation Number
878.4400 FDA UDI
878.4950 FDA UDI
Market of Registration
Belgium EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDIEUDAMEDFDA UDI

Single Use

Yes

FDA UDIFDA 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 UDIFDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDIFDA UDI

Manufacturing Date

No

FDA UDIFDA UDI
Sterilization Method
Ethylene Oxide FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Width — 656 Millimeter FDA UDI
Depth — 48 Millimeter 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

Similar devices

Also classified as Foot-switch, electrical.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
NeuWave Medical, Inc.
EUDAMED SRN
US-MF-000016783
Authorised Representative
Johnson & Johnson Medical GmbH DE-AR-000007712

Sources (7)

  • EUDAMED 5b577bd7-23cb-4cea-908e-c1914b2ff776 61 fields · synced Aug 2, 2026
  • EUDAMED 9af9ef3c-22b1-4814-9536-b7326e50ff61 61 fields · synced May 16, 2026
  • EUDAMED 320ab9cd-7d67-4659-a433-33c92630eb3e 61 fields · synced May 17, 2026
  • EUDAMED 8c84d062-4a11-4e57-a611-47909ebbfcf4 61 fields · synced May 18, 2026
  • FDA UDI 1189f0e5-2506-42aa-b368-0f38e0b7eac2 36 fields · synced May 29, 2026
  • FDA UDI 6b36aef8-f96d-4b56-9c2f-5523c0916817 37 fields · synced May 30, 2026
  • EUDAMED 52d02f54-09ec-4923-909d-aad9b804fffd 61 fields · synced Aug 2, 2026