Question 1

What types of medical devices does Winnomed Company Ltd. manufacture?

Accepted Answer

Winnomed Company Ltd. specializes in manufacturing respiratory medical devices, primarily focusing on breathing bags in various sizes (ranging from 0.25L to 4L). These include silicone and latex-free options, some of which feature over-molded cuffs or standard cuffs. Their portfolio also covers a test lung and pediatric headgear, all designed for medical respiratory applications.

Question 2

Where is Winnomed Company Ltd. based?

Accepted Answer

Winnomed Company Ltd. is based in Taoyuan, Taiwan. The company operates as a contract manufacturer, providing OEM/ODM services for medical devices.

Question 3

Which regulatory registries list Winnomed Company Ltd.’s devices?

Accepted Answer

Winnomed Company Ltd.’s devices are listed in the EU’s eudamed registry. This platform is used to register medical devices authorized for the European market, ensuring transparency and traceability.

Question 4

How are Winnomed Company Ltd.’s devices classified under medical device regulations?

Accepted Answer

All devices manufactured by Winnomed Company Ltd. fall under Class I classification. This classification is typically assigned to low-risk medical devices, such as breathing bags and pediatric headgear, which pose minimal risk to patients when used as intended.

Device	Model / Reference	Registries	Class	Status
Breathing Bag, 2L, Silicone, w/ Cuff	64206	EUDAMED	Class I	Active
Breathing Bag, 0.5L, Silicone, w/ Over-MoldCuff	64204	EUDAMED	Class I	Active
Breathing Bag, 3L, Latex-Free	64103	EUDAMED	Class I	Active
Breathing Bag, 1L, Silicone, w/ Over-MoldCuff	64201	EUDAMED	Class I	Active
Breathing Bag, 2L, Silicone, w/ Over-MoldCuff	64202	EUDAMED	Class I	Active
Breathing Bag, 4L, Latex-Free	64105	EUDAMED	Class I	Active
Breathing Bag, 3L, Silicone, w/ Cuff	64207	EUDAMED	Class I	Active
Breathing Bag, 0.5L, Latex	64114	EUDAMED	Class I	Active
Test Lung	61117	EUDAMED	Class I	Active
Headgear, Pediatric	13102	EUDAMED	Class I	Active
Breathing Bag, 0.25L, Latex-Free	64106	EUDAMED	Class I	Active
Breathing Bag, 2L, Latex	64112	EUDAMED	Class I	Active
Nasal Clamp (Nose Clip)	67101	EUDAMED	Class I	Active
Breathing Bag, 0.5L, Latex-Free	64104	EUDAMED	Class I	Active
Breathing Bag, 4L, Latex	64115	EUDAMED	Class I	Active
Breathing Bag, 3L, Latex	64113	EUDAMED	Class I	Active
Headgear, Adult	13101	EUDAMED	Class I	Active
Breathing Bag, 1L, Silicone, w/ Cuff	64205	EUDAMED	Class I	Active
Breathing Bag, 3L, Silicone, w/ Over-MoldCuff	64203	EUDAMED	Class I	Active
Mouthpiece	26607	EUDAMED	Class I	Active
Breathing Bag, 0.5L, Silicone, w/ Cuff	64208	EUDAMED	Class I	Active
Breathing Bag, 1L, Latex-Free	64101	EUDAMED	Class I	Active
Breathing Bag, 2L, Latex-Free	64102	EUDAMED	Class I	Active
Breathing Bag, 5L, Latex	64116	EUDAMED	Class I	Active

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