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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

K5030 — IVDR Class C IVDR by Nordic Biomarker AB

MD Atlas
Nordic Biomarker AB

EUDAMED last updated this device on Apr 10, 2026

K5030

7350060320056U

On the marketIVDR Class C

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Nordic Biomarker AB
UDI-DI code: 27350060320134
Reference / catalog number: K5030

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View device family (Basic UDI)

Manufacturer information

Organization name: Nordic Biomarker AB
SRN: SE-MF-000022201
Manufacturer status: Active

Related devices

SC106K73500603201773On the market SC107K73500603201875On the market SC105K7350060320297AOn the market 1200117350060320026NOn the market AR037K73500603203473On 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.

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Sweden; available across 3 countries total.

Country	On market since	Until
SwedenPrimary placement		Still on market
Italy		Still on market
Poland		Still on market

Device identification

Trade name: not provided
UDI-DI code: 27350060320134
Basic UDI-DI: 7350060320056U
Reference / catalog number: K5030
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: 10 x 10 mL
Additional information URL: https://www.nordicbiomarker.com/
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

W0103020102ACTIVATED PARTIAL THROMBOPLASTIN TIME

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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