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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

Bact Extra Pure Kit — IVDR Class A IVDR by Clonit srl

MD Atlas
Clonit srl

EUDAMED last updated this device on Feb 2, 2026

Bact Extra Pure Kit

805768091BactXPure_01E8

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Clonit srl
UDI-DI code: 08057680911302
Reference / catalog number: EDR004050

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View device family (Basic UDI)

Manufacturer information

Organization name: Clonit srl
SRN: IT-MF-000022196
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Italy; available across 1 country total.

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

Device identification

Trade name: Bact Extra Pure Kit
UDI-DI code: 08057680911302
Basic UDI-DI: 805768091BactXPure_01E8
Reference / catalog number: EDR004050
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: Bact Extra Pure Kit allows to extract and purify bacterial DNA from the following clinical specimens: uro-genital samples such as urine and vaginal, urethral and cervical swabs, recommending the use of Rayon and Nylon Flocked COPAN swabs (Liquid Based Transport for Microbiology) and respiratory samples: expectorate, bronchoalveolar lavage, nasopharyngeal and pharyngeal swabs for downstream in vitro diagnostic purposes. As an accessory for an in vitro diagnostic medical device it is intended to be used together with one or several particular in vitro diagnostic medical device(s) to specifically enable them to be used in accordance with their intended purpose(s). This kit is for professional use only.
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)08057680911302

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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.

W0105900101REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS

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.

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