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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

FR3,5 — IVDR Class A IVDR by LabMediaServis s.r.o.

MD Atlas
LabMediaServis s.r.o.

EUDAMED last updated this device on Apr 13, 2026

FR3,5

85942104700000000FREU

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: LabMediaServis s.r.o.
UDI-DI code: 08594210470590
Reference / catalog number: FR3,5

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Manufacturer information

Organization name: LabMediaServis s.r.o.
SRN: CZ-MF-000045078
Manufacturer status: Active

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Critical warnings

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

CW009
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.

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: 08594210470590
Basic UDI-DI: 85942104700000000FREU
Reference / catalog number: FR3,5
Issuing entity: GS1

Classification

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

Device details

Quantity: 10
Additional product description: 3,5 ml
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0599IVD GENERAL USE CONSUMABLE DEVICES - 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

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.