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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

TV003-12 — IVDR Class A IVDR by Labex Reagens AB

MD Atlas
Labex Reagens AB

EUDAMED last updated this device on May 6, 2026

TV003-12

73501450010021002SX

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Labex Reagens AB
UDI-DI code: 07350145000346
Reference / catalog number: TV003-12

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View device family (Basic UDI)

Manufacturer information

Organization name: Labex Reagens AB
SRN: SE-MF-000048594
Manufacturer status: Active

Related devices

DI00773501450010011001SJOn the market DI071CT73501450010011001SJOn the market TV00273501450010021002SXOn the market TV00373501450010021002SXOn the market LY06073501450010011001SJOn 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

No critical warnings reported for this device.

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Market distribution

Primary placement in Norway; available across 2 countries total.

Country	On market since	Until
NorwayPrimary placement		Still on market
Sweden		Still on market

Device identification

Trade name: not provided
UDI-DI code: 07350145000346
Basic UDI-DI: 73501450010021002SX
Reference / catalog number: TV003-12
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: Diluent pH7 är avsedd för tvättning av erytrocyter.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)07350145000346

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

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

W01030399IMMUNOHAEMATOLOGY (BLOOD GROUPING) TESTS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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