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Organization name
UDI-DI code
Reference / catalog number

GP0075 — Class I MDD by Hamapharm d.o.o.

MD Atlas
Hamapharm d.o.o.

EUDAMED last updated this device on Feb 6, 2023

GP0075

B-03859892779887

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Hamapharm d.o.o.
UDI-DI code: 03859892779887
Reference / catalog number: GP0075

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Manufacturer information

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

Related devices

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

Critical warnings

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

CW032
Once opened, do not use for more than 6 months.
CW135
EUDAMED did not publish a description for this code.
CW148
Use only in oral cavity.

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: 03859892779887
Basic UDI-DI: B-03859892779887
Reference / catalog number: GP0075
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: gum gel, reduces pain, itching and discomfort due to swollen gums, accelerates the healing of gums during the eruption and loss of the first teeth in children
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

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.