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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

isatuximab CONTROL — IVDR Class A IVDR by sebia

MD Atlas
sebia

EUDAMED last updated this device on Apr 2, 2026

isatuximab CONTROL

3607364764BUFF

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: sebia
UDI-DI code: 03607360047644
Reference / catalog number: 4764

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Manufacturer information

Organization name: sebia
SRN: FR-MF-000003520
Manufacturer status: Active

Critical warnings

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

CW008
EUDAMED did not publish a description for this code.
CW011
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW266
EUDAMED did not publish a description for this code.
CW032
EUDAMED did not publish a description for this code.
CW168
EUDAMED did not publish a description for this code.
CW254
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in France; available across 1 country total.

Placed on the market in France; per-country availability dates not published.

Device identification

Trade name: isatuximab CONTROL
UDI-DI code: 03607360047644
Basic UDI-DI: 3607364764BUFF
Reference / catalog number: 4764
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: No additional product description
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0101050101ASSAYED MULTICOMPONENT CONTROLS (CC)

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.