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Verza Guidance System H44901AM

by Civco Medical Instruments Co., Inc.

Ref H44901AM

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0841436101TD101A1N7 Basic UDI-DI 00841436113632UDI-DIDate16 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841436113632 UDI-DI Date20 Jan 2021ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

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  • Withdrawn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
Verza Guidance System
Generic Name
Ultrasound imaging system tracking positioner, reusable
Device Name
General Purpose Guidance – In-Plane, Fixed Angle (Verza guide)
Model / Ref / Catalog
H44901AM
Description
Reusable non-sterile bracket with Verza™ guides (5) and (14x91.5cm) CIV-Flex™ covers (5), for use with GE Healthcare L2-9 transducers
Primary DI / UDI-DI
00841436113632
Basic UDI-DI
0841436101TD101A1N7
Direct Marketing DI
20841436118310
510(k) Number
FDA Product Code
IYO
EMDN Code
A018002 Needle guides
GMDN Term
Ultrasound imaging system tracking positioner, reusable
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.1560
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Ultrasound imaging system tracking positioner, reusable

Cleared under the same submission (K160806)

Show all (12)

Other devices from Civco Medical Instruments Co., Inc.

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Properties

  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No