e Declaration of Conformity

HOLOGIC Aquilex Fluid Control System

Manufacturer:
Hologic
250 Campus Drive
Marlborough, MA 01752 USA

emg the manuf;acturer of the product ()I'

We, b. s 1sted beIow:
Device Group Name Fluid Control System Tissue Removal Control Unit
Device Name: Aquilex and MySure
GMDNCode: 37649 Fluid Control System
Classification: Group 1, Class A
Product Code (REF) Product Name
INSV09 Fluid Control System
INSVDRV Hysteroscopic Tissue Removal Control Unit
INSVTF0l Monitor
INSVTF12 Rollstand
INSVADPTR Adapter
INSV200 Console
Software ID Software Description
SFW-02510 Gen 2 Console Software
SFW-02441 Gen 2 Handpiece Software

Hereby declare that the above mentioned devices comply with the applicable provisions of the following:

Medical Devices Directive 93/42/EEC as amended by 2007/47/EC

Authorized Representative:
Hologic Ltd
Heron House Oaks Business Park, Crewe Road
Wythenshawe, Manchester, M23 9HZ, UK
Tel: +44 (0)161 946 2206

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 e Declaration of Conformity
HOLOGIC Fluoroscan InSight 2 Mini C-arm

Notified Body Name (if applicable) I Notified Body Designation (if applicable)
British Standards Institution (BSI) I Notified Body Number 0086
Quality System Registration Certificates
FM 508350, expiration 07 October 2024
Quality Management System - ISO 13485:2003
EC Certificates
CE 544674, expiration 09 August 2024
Fu11 Quality Assurance System - Directive 93/42/EEC on Medical Devices , Annex II excluding Section 4

Prepared by: Ginny Kwan, Regulatory Affairs Specialist

Signature:_"""{Jt�-----_-_-_-_-_-_-_________ Date:

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