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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 hCG kit — IVDD — General IVDD by TODA PHARMA

MD Atlas
TODA PHARMA

EUDAMED last updated this device on Jul 11, 2023

Toda hCG kit

B-03760309510187

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: TODA PHARMA
UDI-DI code: 03760309510439
Reference / catalog number: 1028

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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.

CW167
EUDAMED did not publish a description for this code.
CW135
EUDAMED did not publish a description for this code.
CW009
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.
CW007
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 hCG kit
UDI-DI code: 03760309510439
Basic UDI-DI: B-03760309510187
Reference / catalog number: 1028
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 hCG KIT ® is a rapid test for the qualitative detection of hCG hormone in women's urine for the early detection of pregnancy, from the 3rd week of amenorrhea. Based on the combination of antibodies, including an anti-hCG monoclonal antibody, this test can selectively detect high concentrations of hCG.
Additional information URL: https://www.todapharma.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0102160302HCG - RT & POC

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.