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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

503001 — Class I MDR by NAIAX PHARMA S.L.

MD Atlas
NAIAX PHARMA S.L.

EUDAMED last updated this device on Aug 25, 2025

503001

8447070AMB109LW

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: NAIAX PHARMA S.L.
UDI-DI code: 08447070000004
Reference / catalog number: 503001

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Manufacturer information

Organization name: NAIAX PHARMA S.L.
SRN: ES-MF-000041868
Manufacturer status: Active

Critical warnings

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

CW999
Contraindications: allergy to any of the ingredients.
CW999
Warnings and precautions: for external use only. Avoid contact with mouth, eyes or damaged skin. In case of irritation or damage to the skin or eyes wash or rinse with water and get medical advice. Dispose of the product in regular waste. Any unused product or waste material should be disposed of in accordance with local regulations

Market distribution

Primary placement in Poland; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 08447070000004
Basic UDI-DI: 8447070AMB109LW
Reference / catalog number: 503001
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: 3
Additional product description: SORA Protect Gumki do włosów are a lice- repellent band that prevents head lice, i.e. infection of the head by Pediculus humanus capitis. It is recommended for children (over 3 years of age) in case when lice are diagnosed in the child’s environment
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V901001LICE ELIMINATION MECHANICAL DEVICES

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

5030028447070AMB109LWOn 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.