Question 1

What types of medical devices does Produtos Médicos Hospitalares, SA manufacture?

Accepted Answer

Produtos Médicos Hospitalares, SA specializes in manufacturing extension sets, infusion sets, and cannulas with tips for aspiration. These devices are primarily used in intravenous therapy, fluid administration, and medical aspiration procedures, supporting critical hospital and clinical applications.

Question 2

Where is Produtos Médicos Hospitalares, SA based?

Accepted Answer

The company is headquartered in Portugal, operating as a Portuguese manufacturer of medical devices. Its location aligns with EU regulatory frameworks, ensuring compliance with local and European standards for medical device production.

Question 3

Which regulatory registries list the devices manufactured by Produtos Médicos Hospitalares, SA?

Accepted Answer

All devices produced by Produtos Médicos Hospitalares, SA are listed in the EUDAMED database, which is the European Union’s centralised registry for medical devices. This listing confirms their compliance with EU requirements and facilitates transparency for healthcare professionals and regulatory authorities.

Question 4

How are the devices from Produtos Médicos Hospitalares, SA classified under EU regulations?

Accepted Answer

The company’s devices fall under Class I and Class IIa classifications according to EU medical device regulations. This classification is determined by factors like the device’s intended use, risk level, and potential impact on patient safety, with Class IIa indicating a moderate risk requiring additional scrutiny and documentation.

Device	Model / Reference	Registries	Class	Status
Extension sets	310.5047	EUDAMED	Class IIa	Active
Extension sets	301.5094	EUDAMED	Class IIa	Active
Extension sets	306.5093	EUDAMED	Class IIa	Active
Extension sets	307.5052	EUDAMED	Class IIa	Active
Extension sets	307.5053	EUDAMED	Class IIa	Active
Infusion Sets	108.5030	EUDAMED	Class IIa	Active
Cannulas and tips for aspiration	702.0475	EUDAMED	Class IIa	Active
Extension sets	307.1095	EUDAMED	Class IIa	Active
Infusion Sets	108.0200	EUDAMED	Class IIa	Active
Infusion Sets	102.3781	EUDAMED	Class IIa	Active
Extension sets	AMT0045	EUDAMED	Class IIa	Active
Extension sets	306.4732	EUDAMED	Class IIa	Active
Extension sets	302.0710	EUDAMED	Class IIa	Active
Extension sets	AMT0412	EUDAMED	Class IIa	Active
Extension sets	313.4563	EUDAMED	Class IIa	Active
Extension sets	309.0482	EUDAMED	Class IIa	Active
Extension sets	301.0309	EUDAMED	Class IIa	Active
Infusion Sets	110.1624	EUDAMED	Class IIa	Active
Infusion Sets	106.2482	EUDAMED	Class IIa	Active
Extension sets	311.0504	EUDAMED	Class IIa	Active
Non-sterile aspiration tubes - Flexivac bags	705.1495	EUDAMED	Class I	Active
Extension sets	306.1590	EUDAMED	Class IIa	Active
Infusion Sets	103.1851	EUDAMED	Class IIa	Active
Infusion Sets	104.3670	EUDAMED	Class IIa	Active
Extension sets	307.0456	EUDAMED	Class IIa	Active
Infusion Sets	110.0121	EUDAMED	Class IIa	Active
Non-sterile aspiration tubes	703.2673	EUDAMED	Class I	Active
Extension sets	306.3777	EUDAMED	Class IIa	Active
Extension sets	306.4985	EUDAMED	Class IIa	Active
Infusion Sets	110.1868	EUDAMED	Class IIa	Active
Extension sets	303.1606	EUDAMED	Class IIa	Active
Irrigation sets	107.1876	EUDAMED	Class I	Active
Extension sets	307.4428	EUDAMED	Class IIa	Active
Cannulas and tips for aspiration	702.4890	EUDAMED	Class IIa	Active
Infusion Sets	101.0016	EUDAMED	Class IIa	Active
Extension sets	303.0390	EUDAMED	Class IIa	Active
Extension sets	302.2314	EUDAMED	Class IIa	Active
Extension sets	AMT0431	EUDAMED	Class IIa	Active
Extension sets	302.2384	EUDAMED	Class IIa	Active
Non-sterile urine bags	404.0527	EUDAMED	Class I	Active
Extension sets	301.0950	EUDAMED	Class IIa	Active
Urine collection systems and bags	401.0510	EUDAMED	Class I	Active
Infusion Sets	109.2044	EUDAMED	Class IIa	Active
Extension sets	303.1113	EUDAMED	Class IIa	Active
Infusion Sets	106.2289	EUDAMED	Class IIa	Active
Extension sets	306.2201	EUDAMED	Class IIa	Active
Extension sets	306.1780	EUDAMED	Class IIa	Active
Extension sets	302.0068	EUDAMED	Class IIa	Active
Non-sterile aspiration tubes	703.0628	EUDAMED	Class I	Active
Blood administration sets	204.0282	EUDAMED	Class IIa	Active

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