Question 1

What types of medical devices does Taian Dalu Medical Instrument Co., Ltd. manufacture?

Accepted Answer

Taian Dalu Medical Instrument Co., Ltd. specializes in respiratory and inhalation devices. Their product line includes disposable hard-touch universal masks for infants, children, and adults, as well as inhalation systems like metered-dose inhalers (MDI), dry powder inhalers (DPI), and mist inhalers. They also produce branded inhalers such as Nimo, Zeffiro, Virtugal, and sanity, along with free-breathing devices. These products are designed to address common treatments for asthma and COPD.

Question 2

Where is Taian Dalu Medical Instrument Co., Ltd. based?

Accepted Answer

Taian Dalu Medical Instrument Co., Ltd. is based in Taian City, China. The company’s location is relevant for understanding its regulatory compliance and manufacturing operations, particularly in relation to global markets like the EU and the US.

Question 3

Which regulatory registries list Taian Dalu Medical Instrument Co., Ltd.’s devices?

Accepted Answer

Taian Dalu Medical Instrument Co., Ltd.’s devices are listed in the EUDAMED database, which is the European Union’s medical device registry. Additionally, some of their products have been cleared through the FDA’s 510(k) pathway in the United States. These listings reflect compliance with EU and US regulatory requirements for their Class I and Class II/IIa devices.

Question 4

How are Taian Dalu Medical Instrument Co., Ltd.’s devices classified under EU regulations?

Accepted Answer

Taian Dalu Medical Instrument Co., Ltd.’s devices fall under EU Class I and Class II/IIa classifications. Class I devices are generally considered low-risk, while Class II/IIa devices involve a higher level of risk and require additional regulatory scrutiny. The classification determines the regulatory pathway and documentation requirements for market authorization in the EU.

Question 5

What types of inhalation devices does Taian Dalu Medical Instrument Co., Ltd. produce, and why are they relevant?

Accepted Answer

The company produces inhalation devices for three primary methods: metered-dose inhalers (MDI), dry powder inhalers (DPI), and mist inhalers. These devices are critical for delivering medication directly to the lungs, targeting conditions like asthma and COPD. The variety ensures compatibility with different patient needs, such as those requiring precise dosing (MDI), ease of use (DPI), or hydration of medication (mist inhalers). Their inclusion in regulatory databases like EUDAMED and FDA 510(k) reflects their compliance with safety and efficacy standards.

Device	Model / Reference	Registries	Class	Status
Nimo	DL-07	EUDAMED	Class I	Active
UNIVERSAL MASK HARD TOUCH bebés	410011052	EUDAMED	Class I	Active
UNIVERSAL MASK HARD TOUCH infantil	410011053	EUDAMED	Class I	Active
UNIVERSAL MASK HARD TOUCH adultos	410011054	EUDAMED	Class I	Active
Nimo	DL-07	EUDAMED	Class I	Active
Free-Breath	MDN 1201	EUDAMED	Class IIa	Active
Free-Breath	MDN 1201	EUDAMED	Class IIa	Active
Zeffiro	SPC04	EUDAMED	Class IIa	Active
Virtugal	DL-01D ABS-N-01	EUDAMED	Class IIa	Active
sanity	410021060	EUDAMED	Class I	Active
Free-Breath	MDN 1201	EUDAMED	Class IIa	Active
Electronic Peak Flow Meter	K230423	FDA 510(k)	Class II	Active
Universal Mask	410011045	EUDAMED	Class I	Active
Pic Solution	58010328000000	EUDAMED	Class IIa	Active
Vealth	DL-06B PP-N-01	EUDAMED	Class IIa	Active
Pic Solution	58010327000000	EUDAMED	Class IIa	Active
Free-Breath	420011232	EUDAMED	Class IIa	Active
Universal Chamber	DL-01D ABS 175ml	EUDAMED	Class I	Active
Free-Breath	420011233	EUDAMED	Class IIa	Active
Novama	471011004	EUDAMED	Class I	Active
Free-Breath	NA	EUDAMED	Class IIa	Active
Free-Breath	MDN 1201	EUDAMED	Class IIa	Active
Universal Mask	410011044	EUDAMED	Class I	Active
Free-Breath	MDN 1201	EUDAMED	Class IIa	Active
Mediblink	M491	EUDAMED	Class IIa	Active
sanity	420241012	EUDAMED	Class IIa	Active
Free-Breath	MDN 1207	EUDAMED	Class IIa	Active
Anycare	DL03	EUDAMED	Class IIa	Active
AVRON BreathCheck	DL-08B	EUDAMED	Class IIa	Active
lifesense	MD1011	EUDAMED	Class I	Active
Mediblink	M493	EUDAMED	Class IIa	Active
Free-Breath	MDN 1201	EUDAMED	Class IIa	Active
sanity	410021060	EUDAMED	Class I	Active
lifesense	MD1013	EUDAMED	Class IIa	Active
Virtugal	DL-01D ABS-C01-01	EUDAMED	Class IIa	Active
Atomisor Smartchamber	ASCN	EUDAMED	Class IIa	Active
Vitammy	DL-03C ABS-I	EUDAMED	Class IIa	Active
Febelcare	4523-379	EUDAMED	Class IIa	Active
Vitammy	DL-03C ABS-N	EUDAMED	Class IIa	Active
Anycare	DL03	EUDAMED	Class IIa	Active
Free-Breath	MDN 1201	EUDAMED	Class IIa	Active
AVRON BreathCheck	DL-08B	EUDAMED	Class IIa	Active
Pic Solution	58010326000000	EUDAMED	Class IIa	Active

Taian Dalu Medical Instrument Co., Ltd.

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