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Neuwave CTBKT2

by NeuWave Medical, Inc.

Ref CTBKT2

Neuwave CTBKT2 is a microwave ablation system generator (EU MDR Class I; FDA Class I; FDA product code BWN, Table and Attachments, Operating-Room) made by NeuWave Medical, Inc., registered in EUDAMED on 30 Oct 2025 (Basic UDI-DI 081891302a0047K) and listed in FDA GUDID since 3 Nov 2017 (UDI-DI 00853719006463), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081891302a0047K Basic UDI-DI 00853719006463UDI-DIDate30 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00853719006463 UDI-DI Date3 Nov 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081891302a0047K registered 30 Oct 2025 Active
  • FDA GUDID UDI-DI 00853719006463 listed 3 Nov 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00853719006463
  2. Registered EUDAMED 081891302a0047K

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Neuwave
Generic name
Microwave ablation system generator
Device name
NEUWAVE Surgical PDM Mount, CT Bed Rail Mounts
Model / Ref / Catalog
CTBKT2
Primary DI / UDI-DI
00853719006463
Basic UDI-DI
081891302a0047K
Direct marketing DI
00853719006463
FDA product code
BWN
EMDN code
Z12010980 Electrosurgery instruments - hardware accessories
GMDN term
Microwave ablation system generator
Device class
Class I
Regulation number
878.4950
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Size
Depth — 68 Millimeter
Width — 585 Millimeter

Related devices

Category: Microwave ablation system generator

Similar devices in this category

Other devices filed under ELECTROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from NeuWave Medical, Inc.

See all devices from NeuWave Medical, Inc. →

Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)