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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

BIOHIT Extraction tubes — IVDR Class A IVDR by Biohit Oyj

MD Atlas
Biohit Oyj

EUDAMED last updated this device on May 25, 2022

BIOHIT Extraction tubes

6419587BET010S5

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Biohit Oyj
UDI-DI code: 06419587022703
Reference / catalog number: 602270

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Manufacturer information

Organization name: Biohit Oyj
SRN: FI-MF-000014642
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.

CW032
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Finland; available across 1 country total.

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

Device identification

Trade name: BIOHIT Extraction tubes
UDI-DI code: 06419587022703
Basic UDI-DI: 6419587BET010S5
Reference / catalog number: 602270
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: 50
Additional product description: BIOHIT Extraction tubes is an in vitro diagnostic medical device intended for sampling and extraction of calprotectin from human stool samples and to be used with BIOHIT Calprotectin (REF 602260). The product is used manually and is intended to be used by lay persons and healthcare professionals only. The device can only be used once.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W05019001FAECES COLLECTION DEVICES

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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