Medical devices are instruments, apparatuses, appliances, software, materials or other articles for human use that are used alone or in combination, including the software for diagnostic or therapeutic purposes, and that are necessary for their proper use.
Medical devices do not achieve their principle intended action in or on the human body by pharmacological, immunological or metabolic means, although their action may be assisted by such means.
They are intended for:
- Diagnosis, prevention, monitoring, treatment or alleviation of disease
- Diagnosis, monitoring, treatment, alleviation or compensation for an injury or handicap
- Investigation, replacement or modification of the anatomy or of a physiological process
- Control of conception.
Medical devices have a wide scope of action, and some examples of medical devices include: contact lenses, hearing aids, pregnancy test, ECG device with heart rate monitor, glucose meter, thermometers, patches, blood pressure gauges, injection syringes with or without needle, surgical thread, defibrillators etc.
Medical devices are grouped according to the level of risk into:
- Class I – medical devices with low risk for users
- Class IIa – medical devices with medium risk for users
- Class IIb – medical devices with high risk for users
- Class III – medical devices with highest risk for users.
Compared to medicinal products, the difference is that a medical device does not achieve its action by pharmacological, immunological or metabolic means – it is achieved using physical methods (by mechanical means, physical barrier, substitution or support of the role of an organ or body function), while a medicinal product achievesits action by pharmacological, immunological or metabolic means.
Iva Antunović Kršić, VMD / Deputy head of Drug and Medical Devices registration department
Lašćinska cesta 40
Planinska ulica 13/2
Office: +385 1 5588 297
Pharmacovigilance: +385 1 5588 297
Clinical trials: +385 1 5614 330
Registration: +385 1 242 0873
Marketing: +385 1 2420 890
Fax: +385 1 2420 860
Tel: +385 1 5588 297
Full company name
Short company name
Marti Farm Ltd. Trade and Services
Marti Farm Ltd.
Lašćinska cesta 40, HR-10000 Zagreb
Planinska ulica 13/2, HR-10000 Zagreb
a limited liability company
Commercial Court of Zagreb
HRK 20,000.00 (paid in its entirety)
Martina Diminić Smetiško, director of the
company (Representing the company
individually and independently, Responsible
person for data protection)
HR3623600001102197724 (Zagrebačka banka)
HR4324020061100628669 (Erste banka)
Full company name: Marti Farm Ltd. Trade and Services
Short company name: Marti Farm Ltd.
Headquarters: Lašćinska cesta 40, HR-10000 Zagreb
Office: Planinska ulica 13/2, HR-10000 Zagreb
Legal form: a limited liability company
Court register: Commercial Court of Zagreb
Registration number: 080751121
Share capital: HRK 20,000.00 (paid in its entirety)
Authorized representative: Martina Diminić Smetiško, director of the company (Representing the company individually and independently, Responsible person for data protection)
Bank account: HR3623600001102197724 (Zagrebačka banka), HR4324020061100628669 (Erste banka)