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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

SampleFacts InstaSep 40 — IVDR Class A IVDR by SampleFacts AB

MD Atlas
SampleFacts AB

EUDAMED last updated this device on May 20, 2026

SampleFacts InstaSep 40

735017860InstaSepNC

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: SampleFacts AB
UDI-DI code: 07350178600025
Reference / catalog number: 196-316-40

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View device family (Basic UDI)

Manufacturer information

Organization name: SampleFacts AB
SRN: SE-MF-000048513
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Sweden; available across 1 country total.

Country	On market since	Until
SwedenPrimary placement	Jun 30, 2025	Still on market

Device identification

Trade name: SampleFacts InstaSep 40
UDI-DI code: 07350178600025
Basic UDI-DI: 735017860InstaSepNC
Reference / catalog number: 196-316-40
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: SampleFacts InstaSep utilize a combination of filtering and absorbing membranes to instantly separate whole blood into two distinct fractions: blood cells and plasma. When a drop of blood is applied to the card, it immediately divides into these components, which are then dried separately on separate membranes.
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)07350178600025

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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.

W0501010299CAPILLARY BLOOD COLLECTION DEVICES - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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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.