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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

D00324 — IVDR Class B IVDR by IMMUNOTECH s.r.o.

MD Atlas
IMMUNOTECH s.r.o.

EUDAMED last updated this device on Nov 6, 2023

D00324

150995905D00324RC

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: 15099590787486
Reference / catalog number: D00324

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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: 15099590787486
Basic UDI-DI: 150995905D00324RC
Reference / catalog number: D00324
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: AMH Gen II ELISA is an in vitro diagnostic manual medical device intended to be used by healthcare professionals for the quantitative measurement of Anti-Müllerian hormone (AMH) in human serum and plasma. Measurement of AMH is intended to be used for the assessment of fertility status and sexual development. In females, it is used to assess ovarian and menopausal status, including ovarian reserve, and as an aid in diagnosis of PCOS. It is used as an aid in differential diagnosis of intersex conditions in infants.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0102050215ANTI-MÛLLERIAN HORMONE

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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