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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

16-0000-01 — IVDR Class A IVDR by MacroArray Diagnostics

MD Atlas
MacroArray Diagnostics

EUDAMED last updated this device on Sep 25, 2024

16-0000-01

91201229216K3

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: MacroArray Diagnostics
UDI-DI code: 09120122921609
Reference / catalog number: 16-0000-01

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Manufacturer information

Organization name: MacroArray Diagnostics
SRN: AT-MF-000030541
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.

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: 09120122921609
Basic UDI-DI: 91201229216K3
Reference / catalog number: 16-0000-01
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: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0201020101AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)

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

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Certificates

Certificate health across this manufacturer's portfolio.

IQMS/00003/0 v002Supplemented
refdata.certificate-ivdr-type.quality-management-systemNotified body: 2962Expiry: Sep 17, 2029