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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

E453612 — IVDR Class A IVDR by CARLO ERBA Reagents…

MD Atlas
CARLO ERBA Reagents S.A.S.

EUDAMED last updated this device on Oct 11, 2022

E453612

376037353E453612NT

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: CARLO ERBA Reagents S.A.S.
UDI-DI code: 03760373530708
Reference / catalog number: E453612

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Manufacturer information

Organization name: CARLO ERBA Reagents S.A.S.
SRN: FR-MF-000000508
Manufacturer status: Active

Critical warnings

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

CW038
Flam. Liq. 2
CW042
Acute Tox. 3
CW044
STOT SE 1
CW265
Methanol (50%)

Market distribution

Primary placement in Italy; available across 2 countries total.

Country	On market since	Until
ItalyPrimary placement	Jan 1, 2014	Feb 19, 2021
France	Jan 1, 2015	Feb 19, 2021

Device identification

Trade name: not provided
UDI-DI code: 03760373530708
Basic UDI-DI: 376037353E453612NT
Reference / catalog number: E453612
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: Hematology dye for the preparation of samples for optical microscopy.
Additional information URL: https://www.carloerbareagents.com/cerstorefront/cer-fr/search/?text=e453612
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0103010301HISTO / CYTO STAINS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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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.