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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

10021 — Class I MDR by Elysium Laboratories Kft.

MD Atlas
Elysium Laboratories Kft.

EUDAMED last updated this device on Jul 16, 2025

10021

5999862705TCK01S5

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Elysium Laboratories Kft.
UDI-DI code: 05999862705398
Reference / catalog number: 10021

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Manufacturer information

Organization name: Elysium Laboratories Kft.
SRN: HU-MF-000039543
Manufacturer status: Active

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Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW011
Kizárólag külsőleges használatra! Felnőtt vagy felnőtt felügyelete alatt álló személy számára. Gyermekektől távol tartandó. Figyelje a bőrfelületet a kullancs eltávolítása után. Ha bőrpír, duzzanat, kiütés vagy influenzaszerű tünetek jelentkeznek, azonnal forduljon orvoshoz.

Market distribution

Primary placement in Hungary; available across 1 country total.

Placed on the market in Hungary; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 05999862705398
Basic UDI-DI: 5999862705TCK01S5
Reference / catalog number: 10021
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 2
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)

Z120499GENERAL MEDICINE INSTRUMENTS - OTHER

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

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.