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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

CQI KD-TraceColor/PartB –… — IVDR Class B IVDR by KaliDiv

MD Atlas
KaliDiv

EUDAMED last updated this device on Dec 9, 2025

CQI KD-TraceColor/PartB – Particules bleues (flacon de 4 mL)

3770040619TRACECOLORP5Y

On the marketIVDR Class B

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: KaliDiv
UDI-DI code: 03770040619018
Reference / catalog number: Mt11ParBf4

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Manufacturer information

Organization name: KaliDiv
SRN: FR-MF-000047430
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

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

CW160
Do not get in eyes, on skin, or on clothing.
CW162
Wash thoroughly after handling.
CW166
Avoid release to the environment.
CW167
Wear protective gloves/protective clothing/eye protection/face protection.
CW193
IF SWALLOWED: Rinse mouth.
CW206
If skin irritation or rash occurs: Gently wash with plenty of soap and water.
CW208
If skin irritation or rash occurs: Wash with plenty of soap and water.
CW226
Collect spillage.
CW304
If eye irritation persists: Get medical advice/attention.
CW401
IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
CW032
Do not use past indicated date

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: CQI KD-TraceColor/PartB – Particules bleues (flacon de 4 mL)
UDI-DI code: 03770040619018
Basic UDI-DI: 3770040619TRACECOLORP5Y
Reference / catalog number: Mt11ParBf4
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