Question 1

What types of medical devices does Emphasys Importadora, Exportadora e Distribuidora Ltda. manufacture?

Accepted Answer

Emphasys Importadora, Exportadora e Distribuidora Ltda. specializes in inhaler devices for pharmaceutical use. Their portfolio includes dry powder inhalers (DPIs) like the CDA Haler series, which vary in capacity and design, as well as dual-chamber inhalers such as the Dual Haler. These devices are engineered for precise metered dosing of medications, often incorporating features like twist-push mechanisms or anti-static components to meet specific clinical or handling needs.

Question 2

Where is Emphasys Importadora, Exportadora e Distribuidora Ltda. based?

Accepted Answer

The company is based in Brazil, where it operates as a distributor and importer of pharmaceutical inhaler devices. Its regulatory compliance and product listings align with the country’s pharmaceutical standards, though its devices may also be used internationally where applicable regulations permit.

Question 3

Which regulatory registries list the devices manufactured by Emphasys Importadora, Exportadora e Distribuidora Ltda.?

Accepted Answer

The devices produced by Emphasys are listed in the euDaMed database, which is the European Union’s central registry for medical devices. This registry tracks devices that have undergone the necessary conformity assessment procedures under EU regulations, ensuring transparency for healthcare professionals and regulatory authorities.

Question 4

How are the inhaler devices from Emphasys Importadora, Exportadora e Distribuidora Ltda. classified under EU regulations?

Accepted Answer

The inhaler devices in Emphasys’s portfolio fall under Class I and Class IIa classifications according to EU medical device regulations. Class I devices generally pose minimal risk and may require basic conformity assessment, while Class IIa devices involve moderate risk and require additional scrutiny, such as design verification or performance testing, to ensure safety and efficacy before market placement.

Device	Model / Reference	Registries	Class	Status
CDA Haler 180 x 1.00 x 1.0 - O - V1 - R	03-108-10	EUDAMED	Class I	Active
CDA Haler 45 X 1.00 X 1.0 - O - V1 - R	03-085-19	EUDAMED	Class I	Active
Dual Haler DH - 0.8 - R - TP - ABS - NV - III	03-118-34	EUDAMED	Class IIa	Active
CDM Haler 2 x 2 x 2.45	03-76430	EUDAMED	Class I	Active
CDM Haler 2 x 2 x 2.25	03-76429	EUDAMED	Class I	Active
CDA Haler 45 X 1.00 X 1.0 - O - V1 - R - NV	03-085-31	EUDAMED	Class I	Active
Dual Haler - DH 0.8 - R - TP - ABS NV	03-118-29	EUDAMED	Class I	Active
CDA Haler 45 x 1.00 x 1.0 - C - V3	03-085-25	EUDAMED	Class I	Active
CDA Haler 45 x 1.00 x 3.5 - O - V3	03-085-42	EUDAMED	Class IIa	Active
CDA Haler 45 x 1.00 x 1.8 - C - V2 - TP - ABS	03-191-03	EUDAMED	Class I	Active
CDM Haler 2 x 1 x 2.25 -R	03-76515	EUDAMED	Class IIa	Active
CDA Haler 45 x 1.00 x 1.0 - C - V1 - R	03-085-22	EUDAMED	Class IIa	Active
CDA Haler 180 x 1.00 x 3.0 - C - V3	03-108-22	EUDAMED	Class IIa	Active
Maxi Haler NV 45 x 1.00 x 2.0	03-056-11	EUDAMED	Class IIa	Active
CDA Haler 45 x 1.00 x 3.5 - C - V3	03-085-39	EUDAMED	Class I	Active
CDA Haler 45 x 1.00 x 1.8 - O - V1 - R - NV	03-085-32	EUDAMED	Class I	Active
CDA Haler 45 x 2.25 x 3.5 - O - V3	03-085-44	EUDAMED	Class IIa	Active
CDA Haler 180 x 1.00 x 3.0 - C - V1 - R	03-108-28	EUDAMED	Class I	Active
Vertical Haler 3.4mm - R	03-084-14	EUDAMED	Class IIa	Active
CDA Haler 45 x 2.25 x 3.5 - O - V1 - R	03-085-43	EUDAMED	Class IIa	Active
CDA Haler 45 x 1.00 x 3.5 - O - V1 - R	03-085-41	EUDAMED	Class I	Active
CDA Haler 45 x 1.00 x 1.8 - C - V2 - TP - ABS - NV	03-191-05	EUDAMED	Class I	Active
Dual Haler - DH 0.8 - R - TP - ABS	03-118-25	EUDAMED	Class I	Active
CDA Haler 45 x 1.00 x 3.5 - C - V1 - R	03-085-40	EUDAMED	Class IIa	Active
CDM Haler 2 x 2 x 2.25 - R	03-76516	EUDAMED	Class IIa	Active
Maxi Haler NV 45 x 1.00 x 4.4 - R	03-056-00	EUDAMED	Class I	Active
CDA Haler 45 x 1.00 x 1.0 - C - V3 - NV	03-085-30	EUDAMED	Class I	Active
CDA Haler 180 x 1.00 x 1.0 - C - V3 - AE	03-108-37	EUDAMED	Class I	Active
Dual Haler DH - 0.8 - R - TP - ABS - NV - II	03-118-31	EUDAMED	Class IIa	Active
CDM Haler 2 x ½ x 2.25	03-76425	EUDAMED	Class IIa	Active
CDM Haler 2 x ½ x 2.45	03-76426	EUDAMED	Class I	Active
CDM Haler 2 x 1 x 2.45 - R	03-76510	EUDAMED	Class I	Active
Maxi Haler NV 45 x 1.00 x 2.0 - R	03-056-14	EUDAMED	Class IIa	Active
CDM Haler 2 x 1 x 2.25	03-76427	EUDAMED	Class IIa	Active
CDM Haler 2 x ½ x 2.25 - R	03-76499	EUDAMED	Class IIa	Active
CDA Haler 45 x 1.00 x 1.0 - C - V1 - R - NV	03-085-29	EUDAMED	Class I	Active
CDA Haler 45 x 1.00 x 2.2- C - V1 - R - NV	03-085-33	EUDAMED	Class IIa	Active
CDA Haler 45 x 1.00 x 1.8 - O - V1 - R	03-085-20	EUDAMED	Class IIa	Active
CDM Haler 2 x 1 x 2.45	03-76428	EUDAMED	Class IIa	Active
CDA Haler 45 x 1.00 x 1.0 - C- V3 - AE	03-085-47	EUDAMED	Class I	Active
Vertical Haler 3.4mm NV - R	03-084-23	EUDAMED	Class I	Active
CDA Haler 180 x 1.00 x 2.0 - C - V2 - TP - ABS	03-119-07	EUDAMED	Class IIa	Active
CDA Haler 45 x 1.00 x 2.2- C - V1 - R	03-085-21	EUDAMED	Class I	Active
CDM Haler 2 x ½ x 2.45 - R	03-76514	EUDAMED	Class I	Active
CDM Haler 2 x 2 x 2.45 - R	03-76512	EUDAMED	Class IIa	Active

EMPHASYS IMPORTADORA, EXPORTADORA E DISTRIBUIDORA LTDA.

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