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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

0032 — Class I MDR by Insight Instruments Dr.…

MD Atlas
Insight Instruments Dr. Dieter Kropfreiter

EUDAMED last updated this device on May 13, 2024

0032

9120129180032TV

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Insight Instruments Dr. Dieter Kropfreiter
UDI-DI code: 09120129180016
Reference / catalog number: 0032

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Manufacturer information

Organization name: Insight Instruments Dr. Dieter Kropfreiter
SRN: AT-MF-000030221
Manufacturer status: Active

Market distribution

Primary placement in Austria; available across 1 country total.

Placed on the market in Austria; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 09120129180016
Basic UDI-DI: 9120129180032TV
Reference / catalog number: 0032
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Biofeeback-System zur Rückmeldung von relativen Änderungen von physiologischen Parametern
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12062499BIOFEEDBACK INSTRUMENTS - OTHER

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

This device is not currently linked to any other device.

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.