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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

K5009 — IVDD — General IVDD by Nordic Biomarker AB

MD Atlas
Nordic Biomarker AB

EUDAMED last updated this device on Apr 10, 2026

K5009

B-27350060320219

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Nordic Biomarker AB
UDI-DI code: 27350060320219
Reference / catalog number: K5009

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View device family (Basic UDI)

Manufacturer information

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

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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
Romania		Still on market

Device identification

Trade name: not provided
UDI-DI code: 27350060320219
Basic UDI-DI: B-27350060320219
Reference / catalog number: K5009
Issuing entity: GS1

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: 3 x 2,5 mL Latex reagent, 3 x 4 mL Reaction buffer
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.

W0103020612FREE PROTEIN S ANTIGEN

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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