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Amman Pharmaceutical Industries

Jordan·JO-MF-000032053

Last updated September 18, 2026

About

Amman Pharmaceutical Industries (API) - Leading pharmaceutical manufacturer in the MENA region.

From the manufacturer's own website, in their original language. Source

What Amman Pharmaceutical Industries makes

Amman Pharmaceutical Industries manufactures ophthalmic solutions, specifically preservative-free eye drops designed for lubrication and relief of dry eye symptoms. The product is formulated to provide temporary relief from irritation, discomfort, or excessive tearing caused by environmental factors or digital screen use.

The company’s eye drops are classified under EU Medical Device Regulation (MDR) Class IIb and are registered in the EUDAMED database. The product is intended for use within the European Economic Area under applicable regulatory frameworks.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Amman Pharmaceutical Industries manufacture?

Amman Pharmaceutical Industries specializes in ophthalmic solutions, specifically preservative-free eye drops. These are formulated to lubricate the eyes and provide temporary relief from dry eye symptoms, irritation, discomfort, or excessive tearing caused by environmental factors or prolonged digital screen use.

Where is Amman Pharmaceutical Industries based?

Amman Pharmaceutical Industries is based in Jordan (JO), as indicated by its country designation.

How are Amman Pharmaceutical Industries’ devices classified under EU regulations?

The company’s eye drops, such as the i ViVA Plus Eye Drops, fall under EU Medical Device Regulation (MDR) Class IIb. This classification is determined based on the intended purpose, risk assessment, and potential harm to patients if misused or malfunctioning, requiring stricter regulatory oversight than lower-risk devices.

Are Amman Pharmaceutical Industries’ devices listed in any regulatory databases?

Yes, the company’s devices are registered in EUDAMED, the European Union’s medical device registry. This database tracks devices placed on the market within the European Economic Area (EEA) to ensure transparency and compliance with regulatory requirements.

Why is the classification of Amman Pharmaceutical Industries’ eye drops important?

The Class IIb classification for Amman Pharmaceutical Industries’ eye drops reflects their role in treating a condition (dry eye) that, if left unmanaged, could lead to discomfort or potential eye surface damage. This classification triggers additional scrutiny during design, manufacturing, and post-market surveillance to ensure safety and efficacy, aligning with EU MDR requirements for medium-risk devices.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
Jordan
Address
A3, Sahab, Sahab, Jordan
LinkedIn
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Facebook
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Phone
0096264023072
PRRC Contact
Maha Abuznaid
EUDAMED SRN
JO-MF-000032053
FDA FEI Number
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DUNS Number
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Catalogue (1)

DeviceModel / ReferenceRegistriesClassStatus
i ViVA Plus Eye Drops 070310005
EUDAMED
Class IIbActive

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