Organization name

Medasense Biometrics Ltd.

SRN

IL-MF-000022765

Manufacturer status

Active

3 warnings recorded — scroll inside the panel to see all entries.

• CW010

   Read this User Manual before installation and operation of the PMD-200
• CW014

  Type BF applied part
• CW007

   If you noticed that the package was damaged during shipment, do not install the device

Primary placement in Austria; available across 15 countries total.

Trade name

PMD-200

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

07290017287232

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

7290017287PMD2003Z

Reference / catalog number

SYS-1FP-21

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

PMD-200 monitor, ref #PMD200-2

Additional information URL

https://medasense.com/

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z12039080VVARIOUS INSTRUMENTS TO SUPPORT AND MONITOR VITAL SIGNS - HARDWARE ACCESSORIES

• Class IIa medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.