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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

IS0255 — IVDD — General IVDD by C.P.M. COMPAGNIA PER LA…

MD Atlas
C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.

EUDAMED last updated this device on Apr 8, 2025

IS0255

B-IS02559B

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.
UDI-DI code: D-IS02559B
Reference / catalog number: IS0255

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View device family (Basic UDI)

Manufacturer information

Organization name: C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.
SRN: IT-MF-000010738
Manufacturer status: Active

Related devices

C0257B-C0257LTOn the market C0159B-C0159LSOn the market C0162B-C0162LFOn the market C0158B-C0158LQOn the market C0163B-C0163LHOn the market

Critical warnings

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

CW009
EUDAMED did not publish a description for this code.
CW010
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: D-IS02559B
Basic UDI-DI: B-IS02559B
Reference / catalog number: IS0255
Issuing entity: EUDAMED

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: Kit per la taratura (calibrazione) del dosaggio dell’emoglobina glicata (HbA1c) nel sangue intero, mediante procedura immunoturbidimetrica automatizzata
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

EMDN nomenclature code(s)

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

W0101050399CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - 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.