Regulatory Certification

Global Regulatory Clearance Information

Medical devices must be appropriately designed, manufactured, tested and validated against a number of international Standards and Directives for risk management, safety and performance. We strive to provide the highest level of Quality Assurance to our customers with our products and services. This ultimately leads to a safer device and reliable, dependable performance whether in clinical or research applications.

The Medical Devices Directive 93/42/EEC:

CamNtech has CE marked devices in Class 1 and devices classified as ‘non-medical’ based upon their intended use. The table below provides details of the classification within the EU for each device family.

Class (93/42/EEC)
MotionWatch 1
PRO-Diary 1
Actiheart non-medical
Actiwave non-medical

Please contact CamNtech for advice on the suitable aplication of devices.

FDA Clearance (USA):

CamNtech has submitted the required documentation to the United States Food and Drug Administration (FDA) under the 510(k) program. Each device has been found to be substantially equivalent to predicate devices in terms of Indications For Use, design and safety. Each device has been cleared by the FDA to be marketed as a medical device in the USA with the following 510(k) numbers:

 

Class 510(k) number
Actiheart 2 K052489
Actiwave 2 K100266
Motion Watch 2 K132764
PRO-Diary 2 K132764

 

Customers in the USA should contact our Texas office

Australian TGA:

CamNtech has appointed Emergo Group as their Australian sponsor for the MotionWatch and PRO-Diary Motion; any adverse events affecting MotionWatch or PRO-Diary in Australia should be reported directly to Emergo as soon as possible at the following address:

Emergo Australia
Level 20
Tower II, Darling Park
201 Sussex Street
Sydney, NSW 2000
Australia

The MotionWatch and PRO-Diary are listed on the ARTG as Class 1 (non-sterile, non-measuring) with reference 219452. Please click here for the ARTG summary.

Thailand TFDA:

Clearance has been granted by the Thai FDA for all CamNtech products to be legally marketed in Thailand.

Please contact our local distributor in Thailand for all enquiries.

Please click or tap here to view/download the current TFDA certification.

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UK & International customers

CamNtech Ltd.
Manor Farm
Fenstanton
Cambridgeshire
PE28 9JD, UK

US customers

CamNtech Inc.
630 Boerne Stage Airfield,
Boerne,
Texas 78006,
USA

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Company information

Registered in England No. 2221302
VAT No: GB486 3019 34

Company information

VAT No: GB486 3019 34

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