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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

10015 — Class I MDR by Elysium Laboratories Kft.

MD Atlas
Elysium Laboratories Kft.

EUDAMED last updated this device on Jul 16, 2025

10015

5999862705NSL01TQ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Elysium Laboratories Kft.
UDI-DI code: 05999862705312
Reference / catalog number: 10015

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Manufacturer information

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

Critical warnings

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

CW007
EUDAMED did not publish a description for this code.
CW011
- 4 hónaposnál fiatalabb gyermekek, vagy teljesen elzáródott orrnyílással, vagy középfülgyulladásos betegek, vagy eszméletlen személyek az eszközt nem használhatják! - Orrmosáshoz kizárólag tisztított vízben feloldott speciális orrmosó sót szabad használni. - Ne lépje túl a termékleírás vagy a kezelőorvos által meghatározott sóoldat-koncentrációt. - 12 év alatti gyermeken az eszközt kizárólag orvos vagy szülő használhatja. - Orrmosás közben ne beszéljen és ne lélegezzen. - Az orrmosó egyéni higiéniai termék, kizárólag a sajátját használja.

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: 05999862705312
Basic UDI-DI: 5999862705NSL01TQ
Reference / catalog number: 10015
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)

Q030103NASAL IRRIGATION SOLUTIONS

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

Related devices

100205999862705FDR01NMOn the market 100195999862705NSL01TQOn the market 100035999862705NWB01T2On the market 100035999862705NWB01T2On the market 100165999862705NSL01TQOn the market

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.