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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

HYGIA PROTECT — Class I MDR by Sopharma AD

MD Atlas
Sopharma AD

EUDAMED last updated this device on Oct 16, 2024

HYGIA PROTECT

380001063110118P

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Sopharma AD
UDI-DI code: 03800728710895
Reference / catalog number: 31101BGR-0008

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Manufacturer information

Organization name: Sopharma AD
SRN: BG-MF-000019983
Manufacturer status: Active

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Critical warnings

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

CW999
Do not apply on injured skin.
CW999
Do not use for children under 2 years old.
CW032
Do not use after expiry date!
CW011
For external use only!
CW416
Avoid contact with eyes. If a lotion occurs in the eyes, rinse thoroughly with water.
CW161
Not to be used during pregnancy and lactation.
CW405
Stop using the lotion if skin rashes or other signs of allergy occur. Wash skin with soft soap and water and seek medical assistance.

Market distribution

Primary placement in Bulgaria; available across 1 country total.

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

Device identification

Trade name: HYGIA PROTECT
UDI-DI code: 03800728710895
Basic UDI-DI: 380001063110118P
Reference / catalog number: 31101BGR-0008
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: 1
Additional product description: 125 g of the product is packed in polyethylene bottle and round spray pump for direct spraying.
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

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.