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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

Toda Strepdiag B 10 — IVDD — General IVDD by TODA PHARMA

MD Atlas
TODA PHARMA

EUDAMED last updated this device on Aug 30, 2023

Toda Strepdiag B 10

B-03760309513232

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: TODA PHARMA
UDI-DI code: 03760309513232
Reference / catalog number: 1010-10

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Manufacturer information

Organization name: TODA PHARMA
SRN: FR-MF-000007152
Manufacturer status: Active

Critical warnings

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

CW009
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW032
EUDAMED did not publish a description for this code.
CW163
EUDAMED did not publish a description for this code.
CW167
EUDAMED did not publish a description for this code.
CW160
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: Toda Strepdiag B 10
UDI-DI code: 03760309513232
Basic UDI-DI: B-03760309513232
Reference / catalog number: 1010-10
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: TODA STREPDIAG B is a rapid chromatographic immunoassay for the qualitative detection of Strep B antigens from female cervical swab specimens to aid in the diagnosis of Group B Streptococcal infection.
Additional information URL: https://www.todapharma.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0105011104STREP. B DETECTION BY NA REAGENTS

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.