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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

3MSR0920 — IVDR Class A IVDR by DIALAB Produktion und…

MD Atlas
DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.

EUDAMED last updated this device on Oct 4, 2022

3MSR0920

912000735MSPHUMMS438B

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.
UDI-DI code: 09120007358421
Reference / catalog number: 3MSR0920

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Manufacturer information

Organization name: DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.
SRN: AT-MF-000000254
Manufacturer status: Active

Critical warnings

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

CW105
EUDAMED did not publish a description for this code.
CW135
EUDAMED did not publish a description for this code.
CW166
EUDAMED did not publish a description for this code.
CW226
EUDAMED did not publish a description for this code.
CW018
For more details to warnings and precautions refer to IFU.

Market distribution

Primary placement in Austria; available across 2 countries total.

Country	On market since	Until
AustriaPrimary placement	Jul 6, 2022	Still on market
France	Jul 6, 2022	Still on market

Device identification

Trade name: not provided
UDI-DI code: 09120007358421
Basic UDI-DI: 912000735MSPHUMMS438B
Reference / catalog number: 3MSR0920
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: -
Additional information URL: https://www.dialab.at/en/new/info/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0103010105CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

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.