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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

8719324619004 — IVDR Class A IVDR by Labonovum B.V.

MD Atlas
Labonovum B.V.

EUDAMED last updated this device on Oct 3, 2023

8719324619004

11522518719324619004A2

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Labonovum B.V.
UDI-DI code: 08719324619004
Reference / catalog number: 8719324619004

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View device family (Basic UDI)

Manufacturer information

Organization name: Labonovum B.V.
SRN: NL-MF-000023312
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Netherlands; available across 1 country total.

Placed on the market in Netherlands; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 08719324619004
Basic UDI-DI: 11522518719324619004A2
Reference / catalog number: 8719324619004
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: Hem-Col EDTA (ethylene-diamine-tetraacetic acid) where EDTA acts as an anti-coagulant in the blood makes it unpalatable. Other components in the Hem-Col EDTA ensure the preservation of the blood cells for 5 days between 4-25 C. Hem-Col EDTA can be used for hematologic testing.
Additional information URL: https://www.labonovum.nl/en/healthcare-professionals/
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)08719324619004

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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.

W0501010203BLOOD COLLECTION, CAPILLARY TUBES

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.