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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

SHBG-RIACT — IVDD — General IVDD by Cisbio Bioassays

MD Atlas
Cisbio Bioassays

EUDAMED last updated this device on May 20, 2022

SHBG-RIACT

B-03770024321524

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Cisbio Bioassays
UDI-DI code: 03770024321524
Reference / catalog number: SHBG-RIACT

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Manufacturer information

Organization name: Cisbio Bioassays
SRN: FR-MF-000024051
Manufacturer status: Active

Critical warnings

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

CW267
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.
CW265
EUDAMED did not publish a description for this code.
CW028
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: not provided
UDI-DI code: 03770024321524
Basic UDI-DI: B-03770024321524
Reference / catalog number: SHBG-RIACT
Issuing entity: GS1

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: SHBG-RIACT est une trousse qui permet de déterminer la concentration en SHBG (Sex Hormone Binding Globuline) humaine, nommée également TeBG (Testostérone Estradiol Binding Globulin) ou SBP (Sex Binding Protein), dans le sérum ou le plasma. La trousse est destinée à un usage professionnel
Additional information URL: https://www.cisbio.com/ivd-pi
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0102050109SEX HORMONE BINDING GLOBULIN

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

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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.