Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

415634 — IVDR Class A IVDR by CARLO ERBA Reagents…

MD Atlas
CARLO ERBA Reagents S.A.S.

EUDAMED last updated this device on Oct 9, 2025

415634

376037353415634HR

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: 03760373530876
Reference / catalog number: 415634

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

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
Muta. 2 ; Carc. 1B
CW043
Skin Sens. 1
CW265
formaldehyde (4%) CAS 50-00-0

Market distribution

Primary placement in Italy; available across 2 countries total.

Country	On market since	Until
ItalyPrimary placement	Jan 4, 2017	Still on market
France	Aug 4, 2020	Still on market

Device identification

Trade name: not provided
UDI-DI code: 03760373530876
Basic UDI-DI: 376037353415634HR
Reference / catalog number: 415634
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: Fixation solution for the preparation of histological samples for examination in optical microscopy.
Additional information URL: https://www.carloerbareagents.com/cerstorefront/cer-it/search/?text=415634
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

Related devices

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.