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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

526261 — IVDR Class A IVDR by CARLO ERBA Reagents…

MD Atlas
CARLO ERBA Reagents S.A.S.

EUDAMED last updated this device on Jul 22, 2022

526261

376037353526261J7

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: 03760373530289
Reference / catalog number: 526261

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Manufacturer information

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

Critical warnings

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

CW044
Carc. 1B ; Muta. 2
CW038
Skin Irrit. 2 ; Eye Irrit. 2 ; Skin Sens. 1 ; STOT SE 3
CW265
Formaldehyde (9%) Acetic acid (5%) Picric acid (1%)

Market distribution

Primary placement in France; available across 2 countries total.

Country	On market since	Until
FrancePrimary placement	Jan 7, 2015	Still on market
Italy	Nov 14, 2018	Still on market

Device identification

Trade name: not provided
UDI-DI code: 03760373530289
Basic UDI-DI: 376037353526261J7
Reference / catalog number: 526261
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: fixative liquid for organic tissue
Additional information URL: https://www.carloerbareagents.com/cerstorefront/cer-fr/search/?text=526261
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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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.

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