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Organization name
UDI-DI code
Reference / catalog number

LabTest Checker® — Class IIa MDR by LABPLUS Spółka akcyjna

MD Atlas
LABPLUS Spółka akcyjna

EUDAMED last updated this device on May 22, 2026

LabTest Checker®

5904815650LTCII9V

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: LABPLUS Spółka akcyjna
UDI-DI code: 05904815650014
Reference / catalog number: LabTest Checker®

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Manufacturer information

Organization name: LABPLUS Spółka akcyjna
SRN: PL-MF-000048940
Manufacturer status: Active

Related devices

This device is not currently linked to any other device.

Certificates

Certificate health across this manufacturer's portfolio.

G11DK 136905 0001Issued
Quality management systemNotified body: 2443Expiry: Apr 16, 2031

Critical warnings

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

CW999
Key Safety Warnings: LabTest Checker by Labplus® results are for informational purposes only and are not medical advice, consultation, or diagnosis. The system does not replace a medical consultation and cannot be used as the sole diagnostic tool. If you are concerned about your health, contact a doctor immediately. Interpretation of results should be discussed with the attending physician during the next visit Recommendations are not medical referrals.
CW999
Contraindications: Suspicion of a life-threatening or health-threatening condition Emergency / acute conditions requiring immediate medical attention (e.g., trauma, poisoning) Hospitalized patients

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Market distribution

Primary placement in Poland; available across 1 country total.

Country	On market since	Until
PolandPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 05904815650014
Basic UDI-DI: 5904815650LTCII9V
Reference / catalog number: LabTest Checker®
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on 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.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

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