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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

950105 — IVDR Class A IVDR by biosurfit SA

MD Atlas
biosurfit SA

EUDAMED last updated this device on Apr 20, 2026

950105

56006094490DEVICE2B

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: biosurfit SA
UDI-DI code: 05600609449078
Reference / catalog number: 950105

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View device family (Basic UDI)

Manufacturer information

Organization name: biosurfit SA
SRN: PT-MF-000033920
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

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

CW010
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Netherlands; available across 1 country total.

Country	On market since	Until
NetherlandsPrimary placement	May 9, 2019	Still on market

Device identification

Trade name: not provided
UDI-DI code: 05600609449078
Basic UDI-DI: 56006094490DEVICE2B
Reference / catalog number: 950105
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: spinit® strips are non-sterile low sample volume collection strip with a predefined nominal volume for achieving correct amount of sample needed to a specific in vitro test. The spinit® strip is comprised of an elongated body having a handling portion disposed at one end and arranged to provide for gripping and handling means and a sample collecting portion disposed at the other end and arranged to provide for means to receive a volume of a liquid sample. The spinit® strip is used to collect a volume of sample (7.5 - 8 uL) by touching the blood drop or liquid. The device further comprises a frangible portion disposed between the handling portion and the sample collecting portion, wherein the frangible portion is configured to enable complete separation of the sample collecting portion from the sample transfer device.
Additional information URL: https://www.biosurfit.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.

W0501010299CAPILLARY BLOOD COLLECTION DEVICES - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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