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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

RIMPulse Mobile ECG Device and… — Class IIa MDD

MD Atlas
Pulse for Integrated Solutions GmbH

EUDAMED last updated this device on Jul 31, 2024

RIMPulse Mobile ECG Device and System

B-04262384740026

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Pulse for Integrated Solutions GmbH
UDI-DI code: 04262384740026
Reference / catalog number: 4262384740026

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Manufacturer information

Organization name: Pulse for Integrated Solutions GmbH
SRN: DE-MF-000024533
Manufacturer status: Active

Market distribution

Primary placement in XI; available across 1 country total.

Country	On market since	Until
XIPrimary placement		Still on market

Device identification

Trade name: RIMPulse Mobile ECG Device and System
UDI-DI code: 04262384740026
Basic UDI-DI: B-04262384740026
Reference / catalog number: 4262384740026
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12030601COMPLETE VITAL SIGNS TELEMETRY SYSTEMS

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

RIMPulse Android Mobile ApplicationB-04262384740040On the market RIMPulse Android Watch applicationB-04262384740101On the market RIMPulse Apple Watch applicationB-04262384740064On the market RIMPulse firmwareB-04262384740088On the market RIMPulse iOS Mobile applicationB-04262384740057On the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.