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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

EasyExtract — IVDR Class A IVDR by Calpro AS

MD Atlas
Calpro AS

EUDAMED last updated this device on Feb 6, 2024

EasyExtract

709002859510BG

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Calpro AS
UDI-DI code: 07090028595100
Reference / catalog number: CAL0510, CAL0510L

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View device family (Basic UDI)

Manufacturer information

Organization name: Calpro AS
SRN: NO-MF-000036194
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Norway; available across 1 country total.

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

Device identification

Trade name: EasyExtract
UDI-DI code: 07090028595100
Basic UDI-DI: 709002859510BG
Reference / catalog number: CAL0510, CAL0510L
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: 20
Additional product description: The device is intended for sampling and extraction of human stool samples for fecal calprotectin analysis. The sampling can be performed by patient, but the extraction and analysis only by labortatory staff. The device is prefilled with extraction buffer. The extract can be analyzed with Calporlab Calprotectin ELISA or CalproGold Turbidimetric assay.
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)07090028595100

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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.

W05019001FAECES COLLECTION DEVICES

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.