9062

Organization name

Eurospital Spa

SRN

IT-MF-000028468

Manufacturer status

Active

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

• CW073

  EUDAMED did not publish a description for this code.
• CW085

  EUDAMED did not publish a description for this code.
• CW007

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

  EUDAMED did not publish a description for this code.
• CW082

  EUDAMED did not publish a description for this code.
• CW129

  Contains: REACTION MASS OF: 5-CHLORO-2- METHYL-4-ISOTHIAZOLIN-3-ONE [EC NO. 247-500-7]AND 2- METHYL-2H -ISOTHIAZOL-3- ONE [EC NO. 220- 239-6] (3:1)
• CW167

  EUDAMED did not publish a description for this code.
• CW304

  EUDAMED did not publish a description for this code.
• CW225

  EUDAMED did not publish a description for this code.

Primary placement in Italy; available across 1 country total.

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

Trade name

not provided

UDI-DI code

08028169204710

Basic UDI-DI

802816920AW01020608022E

Reference / catalog number

9062

Issuing entity

GS1

Risk category

IVDR Class A

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

EasyCal® is a single-use diagnostic medical device for the pre-analytical processing of stool samples. It allows the extraction of calprotectin from the specific quantity of collected fecal sample, necessary to perform Eurospital Calprest ® and Calprest ®NG assays. For professional use only.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

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

• W0102019009CALPROTECTIN