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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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iSpiro Ultrasonic Sensor — 2 UDI-DI variants, MDR

MD Atlas
eResearchTechnology GmbH

Data from EUDAMED, last updated May 23, 2026

iSpiro Ultrasonic Sensor

4057155Z12150101004C9

2 UDI-DI variants

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

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Manufacturer: eResearchTechnology GmbH

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Device characteristics

Active device

Identity & classification

Basic UDI-DI: 4057155Z12150101004C9
Device name: iSpiro Ultrasonic Sensor
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Version date: Jun 28, 2024

Manufacturer & authorised representative

Manufacturer

Name: eResearchTechnology GmbH
SRN: DE-MF-000008015
Country: Germany
Email: customercare@clario.com
Phone: +49 9 305 720 9891

Variants by status

UDI-DI variants

2 UDI-DI variants

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Applied filters

basicUdiUlid01J1EYV8H2V56EY1867T10NMP7

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

70711504057155000795
89211404057155000801