according to the Medical Device Regulation (MDR) 2017/745

Declaration of Conformity

This declaration of conformity is issued under the sole responsibility of the manufacturer below mentioned. The listed product is herewith confirmed to comply with the requirements set out in the Council Directive on the harmonization of the Laws of the Member States concerning Regulation (EU) MDR 2017/745 for medical devices (Annex IX – Conformity Assessment Based on a Quality Management System and Assessment of Technical Documentation) certified by DNV Product Assurance AS (notified body number – 2460). The product also complies with Council Directives 2011/65/EU (RoHS) and 2014/53/EU (RED).

For the following equipment:

Product Name: Index™ BPM

Model Designation / Brand Name: BP707 / Garmin

Manufacturer Name: Ya Horng Electronic Co., Ltd.

Factory: Ya Horng (Dongguan) Electronic Co., Ltd.

Manufacturer Address: No.35, Shalun, Anding Dist., Tainan City 745, Taiwan

Factory Address: Room 201, Building #9, No. 84 Gaoyu South Road, Tangxia Town, Dong Guan, Guangdong, China

Single Registration Number (SRN): TW-MF-000010109

EU MDR certificate number issued and expiry:

Certificate No.: C539652

Initial Certification Date: 30 August 2023

Valid Until: 30 August 2028

Basic UDI-DI: 471987331BP2021A8G

Notified Body Name: DNV Product Assurance AS

Notified Body Number: CE 2460

Notified Body Address:

Veritasveien 1

1363 Høvik

Country: Norway

Intended Purpose: The Index BPM device is a tubeless blood pressure monitor. This is a medical device intended to measure systolic and diastolic blood pressure and pulse rate. The device is designed for measurement and operation by adults age 18 to 75. The device is designed to measure adults (age 18 to 75) with an upper arm circumference of 22 to 42 cm (8.6 to 16.5 in.).

Disclaimer: The Index BPM device is not intended to diagnose any disease. Only a physician is qualified to diagnose and treat diseases, including high blood pressure. You should contact your physician if the device displays hypertensive or high blood pressure values. There are no known side effects for using this device. The Index BPM device is a standalone device and you are not required to connect the device to a smartphone app. The optional smartphone app can only be used to store data for personal record keeping. The app does not perform an action on data, or perform an action beyond storage.

GMDN Code: 45617 Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

CND Code: Z1203020501 OSCILLOMETRIC NON INVASIVE BLOOD PRESSURE MONITORS

Classification: Class IIa MDR 2017/745 Annex VIII, Rule 10

Declared under the sole responsibility of the manufacturer mentioned above.

It is herewith confirmed to comply with the requirements set out in the Council Directive on the harmonization of the Laws of the Member States concerning Regulation (EU) MDR 2017/745 for medical devices- Annex IX CONFORMITY ASSESSMENT BASED ON A QUALITY MANAGEMENT SYSTEM AND ON ASSESSMENT OF TECHNICAL DOCUMENTATION to be certified by DNV GL Presafe AS(notified body number - 2460). For the evaluation regarding the Class IIa product safety aspects, the following harmonized standards are applied:

I, EU Harmonised Standards

II, International Standards

• ISO 14971:2019: Medical devices -- Application of risk management to medical devices

• IEC 60601-1: 2005+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

• ISO 81060-2:2018+A1:2020 Non-invasive sphygmomanometers — Part 2: Clinical investigation of intermittent automated measurement type

• IEC 80601-2-30: 2018: Medical electrical equipment -- Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers

• IEC 60601-1-11:2015 : Medical electrical equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

• IEC 60601-1-2:2014 : Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

• ISO 10993-1: 2018: Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process

• ISO 10993-5: 2009 : Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity

• ISO 10993-10: 2010 : Biological evaluation of medical devices. Tests for irritation and skin sensitization

• IEC 60601-1-6:2010+A1: 2013 : Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

• IEC 62366-1: 2015/COR:2016: Medical devices - Application of usability engineering to medical devices

• ISO 15223-1:2021 : Medical devices -- Symbols to be used with medical device labels, labeling and information to be supplied -- Part 1: General requirements

• IEC 62304:2006+A1 :2015 : Medical device software – Software life cycle processes

III, EU Common Specifications (CS)

• No applicable CS regulations

The following manufacturer/importer or authorized representative is responsible for this declaration:

Kahl Handelsvertretung

Isarstr. 33 40699 Erkrath Germany

Person responsible for the manufacturer for making this declaration:

Jerry Hsu, General Manager

Ya Horng