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Organization name
UDI-DI code
Reference / catalog number

GP0069 — Class I MDD by Hamapharm d.o.o.

MD Atlas
Hamapharm d.o.o.

EUDAMED last updated this device on Feb 6, 2023

GP0069

B-03859892779788

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Hamapharm d.o.o.
UDI-DI code: 03859892779788
Reference / catalog number: GP0069

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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

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

1 warning recorded — scroll inside the panel to see all entries.

CW262
One package should be used by one person. do not use close to the eyes, nose or mouth. in case of medical problems with outer ear consult your doctor before use.

Market distribution

Primary placement in Croatia; available across 1 country total.

Country	On market since	Until
CroatiaPrimary placement	Feb 25, 2021	Still on market

Device identification

Trade name: not provided
UDI-DI code: 03859892779788
Basic UDI-DI: B-03859892779788
Reference / catalog number: GP0069
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: oil ear spray, to soften and remove ear wax and prevent ear canal inflammation
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q030499OTOLOGY DEVICES - OTHER

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