8001661

Organization name

BIOSYNEX

SRN

FR-MF-000014073

Manufacturer status

Active

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• CW010

  EUDAMED did not publish a description for this code.

Primary placement in France; available across 1 country total.

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

Trade name

not provided

UDI-DI code

03532670504009

Basic UDI-DI

353267F00177N8U

Reference / catalog number

8001661

Issuing entity

GS1

Risk category

IVDR Class A

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

LabPad Evolution is an automated Point of Care (PoC) multimeasurements testing device to perform quantitative, semi-quantitative or qualitative In Vitro Diagnostic (IVD) rapid tests from a small volume of biologic sample such as blood, urine, nasal swab etc. It is intended for near patient testing by trained health care professionals. This device must be operated only with a range of single use compatible tests.

Additional information URL

https://www.biosynex.com/

Clinical sizes

No clinical sizes registered for this device.

• W0201069099VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER

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• Expiration date
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• Serial number
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