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Organization name
UDI-DI code
Reference / catalog number

C55857 — IVDR Class B IVDR by IMMUNOTECH s.r.o.

MD Atlas
IMMUNOTECH s.r.o.

EUDAMED last updated this device on Nov 6, 2023

C55857

150995905FT4PlusY3

On the marketIVDR Class B

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: IMMUNOTECH s.r.o.
UDI-DI code: 15099590774172
Reference / catalog number: C55857

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Manufacturer information

Organization name: IMMUNOTECH s.r.o.
SRN: CZ-MF-000001761
Manufacturer status: Active

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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.

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
see IFU

Market distribution

Primary placement in Czechia; available across 1 country total.

Country	On market since	Until
CzechiaPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 15099590774172
Basic UDI-DI: 150995905FT4PlusY3
Reference / catalog number: C55857
Issuing entity: GS1

Classification

Risk category: IVDR Class B
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: FT4 Plus RIA is an in vitro diagnostic manual medical device intended to be used by healthcare professionals for the quantitative measurement of free thyroxine (FT4) in human serum and plasma. Measurement of free thyroxine is intended to be used as an aid in diagnosis of thyroid disorders in general population.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01020402FREE THYROXINE

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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