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Organization name
UDI-DI code
Reference / catalog number

GP0035 — Class I MDD by Hamapharm d.o.o.

MD Atlas
Hamapharm d.o.o.

EUDAMED last updated this device on Feb 6, 2023

GP0035

B-03859892779818

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Hamapharm d.o.o.
UDI-DI code: 03859892779818
Reference / catalog number: GP0035

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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

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

CW135
Only for external use on skin. Do not use with wraps and bandages. after use wash hands with water and soap thoroughly.
CW085
Do not use on open wounds, avoid contact with eyes and mucosa. In case of contac with eyes rinse thoroughly.
CW032
EUDAMED did not publish a description for this code.
CW062
Do not use near heating source.
CW161
Do not use during pregnancy or breastfeeding. Do not use in children under 5 years.
CW275
Ask your doctor or pharmacist if symptoms persist.
CW406
After use wash with soap and water.

Market distribution

Primary placement in Croatia; available across 1 country total.

Country	On market since	Until
CroatiaPrimary placement	Apr 12, 2021	Still on market

Device identification

Trade name: not provided
UDI-DI code: 03859892779818
Basic UDI-DI: B-03859892779818
Reference / catalog number: GP0035
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: gel, to relieve and soothe pain such as muscle pain, sports injuries and mild post-traumatic pain, reduces swelling, as an adjunct to therapy for acute muscle and joint pain
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - 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
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Software identification