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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 MED — Class I MDR by Sopharma AD

MD Atlas
Sopharma AD

EUDAMED last updated this device on Oct 2, 2024

HYGIA MED

380001063110138T

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Sopharma AD
UDI-DI code: 03800728710888
Reference / catalog number: 31101BGR-0010

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Manufacturer information

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

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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.

Critical warnings

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

CW009
Re-use is possible no earlier than 7 days after the first use.
CW275
For pregnant women - there are no contraindications regarding the use of Hygia MED Shampoo. However, it is recommended to seek advice from doctor or pharmacist.
CW999
Do not use for children under 3 years of age.
CW999
Do not use in case of open wounds, injuries or infectious diseases of the scalp.
CW032
Do not use after expiry date!
CW416
Avoid getting the shampoo in the eyes, mouth or nose. If this happens, wash the area immediately with water.
CW011
Do not use in case of hypersensitivity to any of the shampoo components.

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 MED
UDI-DI code: 03800728710888
Basic UDI-DI: 380001063110138T
Reference / catalog number: 31101BGR-0010
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: Product of 120 g is package together with comb for easily removing nits when combing.
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