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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

IC401 — IVDR Class A IVDR by Pro-Eko Srl

MD Atlas
Pro-Eko Srl

EUDAMED last updated this device on Jan 10, 2024

IC401

805624938W01030708KLU

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Pro-Eko Srl
UDI-DI code: 80562493801770
Reference / catalog number: IC401

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View device family (Basic UDI)

Manufacturer information

Organization name: Pro-Eko Srl
SRN: IT-MF-000030078
Manufacturer status: Active

Related devices

IC012.250805624938W010307089LOn the market IC003.500805624938W010307089LOn the market IC002.250805624938W010307059EOn the market IC002.500805624938W010307059EOn the market IC004.500805624938W010307089LOn the market

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.

Critical warnings

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

CW057
EUDAMED did not publish a description for this code.
CW075
EUDAMED did not publish a description for this code.
CW079
EUDAMED did not publish a description for this code.
CW099
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: not provided
UDI-DI code: 80562493801770
Basic UDI-DI: 805624938W01030708KLU
Reference / catalog number: IC401
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: Kit di colorazione rapida citologica
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)80562493801770

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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.

W01030708STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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