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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

IQC KD-Ag/P.falciparum — IVDR Class B IVDR by KaliDiv

MD Atlas
KaliDiv

EUDAMED last updated this device on Dec 9, 2025

IQC KD-Ag/P.falciparum

3770040619CQIAGPCRPFALTC

On the marketIVDR Class B

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: KaliDiv
UDI-DI code: 03770040619087
Reference / catalog number: Mt21Pf1/3

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Manufacturer information

Organization name: KaliDiv
SRN: FR-MF-000047430
Manufacturer status: Active

Critical warnings

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

CW167
Wear protective gloves/protective clothing/eye protection/face protection.
CW008
Biological risks
CW406
IF ON SKIN: Gently wash with plenty of soap and water.
CW416
IF IN EYES: Rinse cautiously with water for several minutes.
CW304
If eye irritation persists: Get medical advice/attention.
CW307
IF SWALLOWED: Get medical advice/attention.
CW133
To avoid risks to human health and the environment, comply with the instructions for use.
CW160
Do not get in eyes, on skin, or on clothing.
CW163
Do not eat, drink or smoke when using this product.

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement		Still on market

Device identification

Trade name: IQC KD-Ag/P.falciparum
UDI-DI code: 03770040619087
Basic UDI-DI: 3770040619CQIAGPCRPFALTC
Reference / catalog number: Mt21Pf1/3
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01040699CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER

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.