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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

10017 — Class I MDR by Elysium Laboratories Kft.

MD Atlas
Elysium Laboratories Kft.

EUDAMED last updated this device on Jul 16, 2025

10017

5999862705NSL01TQ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Elysium Laboratories Kft.
UDI-DI code: 05999862705350
Reference / catalog number: 10017

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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: 05999862705350
Basic UDI-DI: 5999862705NSL01TQ
Reference / catalog number: 10017
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

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.

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