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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

446377 — IVDR Class A IVDR by CARLO ERBA Reagents…

MD Atlas
CARLO ERBA Reagents S.A.S.

EUDAMED last updated this device on Oct 12, 2022

446377

376037353446377K4

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: 03760373530722
Reference / catalog number: 446377

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Manufacturer information

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

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492011376037353492011JJOn the market 526274376037353526274JGOn the market https://www.carloerbareagents.com/cerstorefront/cer-fr/search/?text=446466376037353446466K4On the market E490451376037353E490451PJOn the market 526270376037353526270J8On 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

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

CW044
STOT SE 2
CW043
Acute Tox. 4
CW265
Methanol

Market distribution

Primary placement in Italy; available across 2 countries total.

Country	On market since	Until
ItalyPrimary placement	Jun 22, 2017	Still on market
France	Aug 2, 2019	Still on market

Device identification

Trade name: not provided
UDI-DI code: 03760373530722
Basic UDI-DI: 376037353446377K4
Reference / catalog number: 446377
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: Intended use Nucleic staining with hematoxylin.
Additional information URL: https://www.carloerbareagents.com/cerstorefront/cer-fr/search/?text=446377
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01030708STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
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Software identification