STRIDE BP Review of an Equivalent/Identical Device

STRIDE BP accepts applications for approving new devices with Equivalent/Identical BP measurement mode.

EQUIVALENT Device Application

No differences between devices in elements affecting the BP measurement accuracy (see Technical information below), but differences in elements not affecting BP measurement accuracy.

IDENTICAL Device Application*

No differences between devices.

* If your new device is IDENTICAL to a device which currently appears at STRIDE BP website and is also EQUIVALENT to another device, again appearing at STRIDE BP website, please submit only data for the two IDENTICAL devices.

For a new device to be reviewed and potentially approved, the application must provide the following information for both reference and equivalent/identical device:

  1. Technical information
    1. Signal sensor (Transducer) and processing
    2. Blood pressure estimation algorithm
    3. Inflation and deflation system
    4. Cuff size and shape
  2. Manuals
  3. Devices’ photos
  4. Cuffs’ photos
  5. Links to manufacturer’s dedicated device pages

A payment of € 600 (+VAT if applicable) to STRIDE BP (bank account details shown below) is necessary for reviewing this application irrespective of approval or rejection of the Equivalence/Identical Device. This means that you must provide the transaction number of the payment.

STRIDE BP bank account details:

VAT: 996826308
Branch: 0359
Address: Leof. Kifisias 218, Chalandri 15231, Athens, Greece
Account No: 359002320006977
IBAN: GR3601403590359002320006977
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