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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

EasyCal® FOB — IVDR Class A IVDR by Eurospital Spa

MD Atlas
Eurospital Spa

EUDAMED last updated this device on Mar 5, 2026

EasyCal® FOB

802816920AW01020608042J

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Eurospital Spa
UDI-DI code: 08028169207452
Reference / catalog number: 9293

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View device family (Basic UDI)

Manufacturer information

Organization name: Eurospital Spa
SRN: IT-MF-000028468
Manufacturer status: Active

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Calprest ® NG-S802816920BW01020608023KOn the market Calprest® Turbo Extraction Kit802816920AW01020608052LOn the market Easy-NAT802816920AW02060609015COn the market 9062802816920AW01020608022EOn the market 9191EP802816920BW01020608053ROn the market

Critical warnings

4 warnings recorded — scroll inside the panel to see all entries.

CW132
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.

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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: EasyCal® FOB
UDI-DI code: 08028169207452
Basic UDI-DI: 802816920AW01020608042J
Reference / catalog number: 9293
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: EasyCal® FOB is a single-use diagnostic medical device for the pre-analytical processing of stool samples. It allows the extraction of hemoglobin (Hb) from the specific quantity of collected fecal sample, necessary to perform the Eurospital FOB-Test Turbo. For professional laboratory 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)08028169207452

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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.

W0102039013FECAL OCCULT BLOOD (IC)

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.