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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

CAL220 — IVDD — General IVDD by Calpro AS

MD Atlas
Calpro AS

EUDAMED last updated this device on May 11, 2026

CAL220

B-07090028592208

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Calpro AS
UDI-DI code: 07090028592208
Reference / catalog number: CAL220

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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.

Country	On market since	Until
NorwayPrimary placement	Oct 24, 2016	Dec 31, 2029

Device identification

Trade name: not provided
UDI-DI code: 07090028592208
Basic UDI-DI: B-07090028592208
Reference / catalog number: CAL220
Issuing entity: GS1

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: CalproSmart office™ is a rapid test intended as a diagnostic tool at laboratories, clinics, and doctors’ offices for the determination of Calprotectin in human stool samples in combination with the dedicated CalprosmartTM smartphone application to: 1. Differentiate between inflammatory bowel diseases (IBD) and Irritable Bowel Syndrome (IBS) 2. A tool to predict relapse, identify effect of treatment of IBD-patients, and/or identify non responders
Additional information URL: https://calpro.no/calprosmart-office/
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)07090028592208

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

W0101060399FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER

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.