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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

429751 — IVDR Class A IVDR by CARLO ERBA Reagents…

MD Atlas
CARLO ERBA Reagents S.A.S.

EUDAMED last updated this device on Jul 18, 2022

429751

376037353429751K5

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: 03760373530036
Reference / catalog number: 429751

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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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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
Muta. 2 ; Carc. 1B
CW043
Acute Tox. 4 (skin, inhaled); Skin Irrit. 2; Eye Irrit. 2; Skin Sens. 1;STOT SE 3
CW265
formaldehyde (16%); 2,4,6-trinitrophenol (1%)

Market distribution

Primary placement in Italy; available across 2 countries total.

Country	On market since	Until
ItalyPrimary placement	Mar 11, 2014	Still on market
France	May 3, 2018	Still on market

Device identification

Trade name: not provided
UDI-DI code: 03760373530036
Basic UDI-DI: 376037353429751K5
Reference / catalog number: 429751
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: intented use By fixation we mean the inactivation of the lysing enzymes of the bacteria that cause tissue putrefaction and the conferment of structural stability to the chemical constituents of the protoplasm. Fixatives are able to denature proteins and make other cellular constituents insoluble. Bouin's fixative is one of the best fixatives used in histology. It has a good ability to penetrate tissues and therefore is used to fix parts of organs, even bulky ones, and allows the use of almost all staining methods. It can be used to prepare ensemble and cytological preparations. It is considered the most suitable fixative in endocrine and neuroendocrine pathology.
Additional information URL: https://www.carloerbareagents.com/cerstorefront/cer-it/search/?text=429751
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01030705FIXING REAGENTS (HISTOLOGY/CYTOLOGY)

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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