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Organization name
UDI-DI code
Reference / catalog number

GP0086 — Class I MDD by Hamapharm d.o.o.

MD Atlas
Hamapharm d.o.o.

EUDAMED last updated this device on Feb 6, 2023

GP0086

B-03859892779917

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Hamapharm d.o.o.
UDI-DI code: 03859892779917
Reference / catalog number: GP0086

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Manufacturer information

Organization name: Hamapharm d.o.o.
SRN: HR-MF-000023827
Manufacturer status: Active

Critical warnings

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

CW148
EUDAMED did not publish a description for this code.
CW135
EUDAMED did not publish a description for this code.
CW010
Do not use in case of hypersenitivity to any of ingredients.
CW262
Do not use near eyes or nose. Only for use in oral cavity. if your simptoms do not improve consult your healthcare professional.
CW032
Do not use longer than six month after opening.

Market distribution

Primary placement in Croatia; available across 1 country total.

Country	On market since	Until
CroatiaPrimary placement	Apr 9, 2021	Still on market

Device identification

Trade name: not provided
UDI-DI code: 03859892779917
Basic UDI-DI: B-03859892779917
Reference / catalog number: GP0086
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: mouthwash, reduces pain, irritation and discomfort in the mouth, accelerates the healing of gums and acts effectively as a prevention in the formation of new lesions
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V9017ORAL ADMINISTRATION PREPARATIONS NOT INCLUDED IN OTHER CLASSES

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

GU0070B-03859892779740On the market GU0060B-03859892779733On the market GP0017B-03859892779313On the market GP0001B-03859892779344On the market GU0065B-03859892779726On 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.