Question 1

What types of medical devices does Hangzhou Hua'An Medical & Health Instruments Co., Ltd. manufacture?

Accepted Answer

Hangzhou Hua'An Medical & Health Instruments Co., Ltd. produces a range of medical devices, including patient monitoring systems like the LIFESYNE VITALS for tracking vital signs, digital thermometers such as the BIOSYNEX and MEDICAID (both designed for rapid, flexible, and universal use), and portable medical equipment like the infineed series and AEG. They also offer disposable medical accessories under brands like santecare and LIVSANE. These devices cater to both single-use and reusable applications.

Question 2

Where is Hangzhou Hua'An Medical & Health Instruments Co., Ltd. based?

Accepted Answer

The company is based in China, as indicated by its country designation. This geographic location influences its regulatory compliance and market reach, particularly for devices intended for international use.

Question 3

Which regulatory registries list the devices manufactured by Hangzhou Hua'An Medical & Health Instruments Co., Ltd.?

Accepted Answer

The company’s devices are listed in the eudamed database, which is the European Union’s central registry for medical devices. This inclusion ensures transparency and compliance with EU Medical Device Regulations for devices marketed within the EU.

Question 4

How are the devices from Hangzhou Hua'An Medical & Health Instruments Co., Ltd. classified under EU regulations?

Accepted Answer

The company’s devices are classified under the EU Medical Device Regulations as either Class I (generally low-risk devices) or Class IIa (moderate-risk devices). Classification depends on factors like intended use, duration of contact with the body, and potential risks, as defined by EU legislation. This classification determines the regulatory requirements for their placement on the market.

Device	Model / Reference	Registries	Class	Status
Digital thermometer	DT-01A	EUDAMED	Class IIa	Active
Lifesyne Vitals	DT-K111B	EUDAMED	Class IIa	Active
infineed	THED	EUDAMED	Class IIa	Active
infineed	THED	EUDAMED	Class IIa	Active
infineed	THED	EUDAMED	Class IIa	Active
BIOSYNEX Thermometre Souple et Rapide 10 secondes Universal	860986	EUDAMED	Class IIa	Active
Lifesyne Vitals	DT-K111B	EUDAMED	Class IIa	Active
Livsane	DT-K111D	EUDAMED	Class IIa	Active
Aeg	DT-01E	EUDAMED	Class IIa	Active
MEDICAID Thermometre Souple et Rapide 10 secondes Universal	860996	EUDAMED	Class IIa	Active
Lifesyne Vitals	DT-K111B	EUDAMED	Class IIa	Active
santecare	DT-101B	EUDAMED	Class IIa	Active
Alvita	IET2PC	EUDAMED	Class I	Active
Medi Pro	DT-01D	EUDAMED	Class IIa	Active
Qute	DT-K111B	EUDAMED	Class IIa	Active
ＬａｂｏｒａｔｏｉｒｅｓＥｕｒｏｍｅｄｉｓ	DT-11A	EUDAMED	Class IIa	Active
babydrogist	DT-111G	EUDAMED	Class IIa	Active
Ma Référence	DT-K111B	EUDAMED	Class IIa	Active
Brannan	DT-01D	EUDAMED	Class IIa	Active
+well	IET2PC	EUDAMED	Class I	Active
Kinetik	ET-100A	EUDAMED	Class IIa	Active
Biosynex	942601	EUDAMED	Class IIa	Active
Neocare	DT-111G	EUDAMED	Class IIa	Active
Kinetik	IET 3PC	EUDAMED	Class I	Active
Meditemp	624215	EUDAMED	Class IIa	Active
ia	DT-K11E	EUDAMED	Class IIa	Active
Joleti	1512042000	EUDAMED	Class IIa	Active
Vivomed	74000063	EUDAMED	Class IIa	Active
iproven	BBT-113Ai	EUDAMED	Class IIa	Active
santecare	DT-101B	EUDAMED	Class IIa	Active
Farmaricci	DT-101A	EUDAMED	Class IIa	Active
Pharmactiv	DT-K111B	EUDAMED	Class IIa	Active
VP natura	DT-K111I	EUDAMED	Class IIa	Active
Emancipees	DT-K111D	EUDAMED	Class IIa	Active
Biosynex	455817	EUDAMED	Class IIa	Active
Marque Conseil	DT-K111B	EUDAMED	Class IIa	Active

HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., LTD.

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