Question 1

What types of medical devices does Wenzhou Wanray Glasses Co., Ltd manufacture?

Accepted Answer

Wenzhou Wanray Glasses Co., Ltd specializes in prescription glasses, including lenses designed for vision correction such as anti-blue light and presbyopic lenses. Their product range also includes specialized eyewear labeled as MA, PHARMACTIV, and BE WHITE, which may address specific optical or health-related needs. These devices are primarily intended for correcting vision or reducing eye strain.

Question 2

Where is Wenzhou Wanray Glasses Co., Ltd based?

Accepted Answer

The company is headquartered in China. While their primary market may be domestic, their devices are also registered in the European market, indicating compliance with regional regulatory requirements.

Question 3

Which regulatory registries list Wenzhou Wanray Glasses Co., Ltd’s devices?

Accepted Answer

The company’s devices are listed in the EUDAMED database, which is the European Union’s medical device registry. This registration is required for devices marketed within the EU, ensuring transparency and traceability under EU medical device regulations.

Question 4

How are Wenzhou Wanray Glasses Co., Ltd’s devices classified under EU regulations?

Accepted Answer

All of Wenzhou Wanray Glasses Co., Ltd’s listed devices fall under Class I classification in the EU. This classification applies to low-risk devices like many types of prescription glasses, including anti-blue light and corrective lenses, which pose minimal risk to users when used as intended.

Device	Model / Reference	Registries	Class	Status
Be White	Hadrien C2	EUDAMED	Class I	Active
Be White	Hadrien C6	EUDAMED	Class I	Active
Be White	BW25V-001 C1	EUDAMED	Class I	Active
Be White	BW24V-027 C1	EUDAMED	Class I	Active
Be White	BW24S-024 C2	EUDAMED	Class I	Active
Be White	Yari C4	EUDAMED	Class I	Active
Be White	Sabine C2	EUDAMED	Class I	Active
Be White	BW25S-001 C3	EUDAMED	Class I	Active
Be White	BW25S-002 C2	EUDAMED	Class I	Active
Be White	BW24V-057 C3	EUDAMED	Class I	Active
Be White	BW24S-001 C3	EUDAMED	Class I	Active
Be White	BW24V-026 C4	EUDAMED	Class I	Active
Be White	Yara C2	EUDAMED	Class I	Active
Ma	RETRO	EUDAMED	Class I	Active
Be White	BW24V-005 C3	EUDAMED	Class I	Active
Be White	BW24S-027 C1	EUDAMED	Class I	Active
Pharmactiv	CLASSIQUE	EUDAMED	Class I	Active
Be White	BW24V-057 C2	EUDAMED	Class I	Active
PC anti blue presbyopic glasses	3	EUDAMED	Class I	Active
Be White	BW24V-001 C4	EUDAMED	Class I	Active
Be White	Yara C5	EUDAMED	Class I	Active
Be White	BW24V-027 C3	EUDAMED	Class I	Active
Be White	BW25S-004 C5	EUDAMED	Class I	Active
Be White	BW24S-024 C3	EUDAMED	Class I	Active
Be White	BW25S-005 C1	EUDAMED	Class I	Active
Pharmactiv	TENDANCE	EUDAMED	Class I	Active
Be White	BW24V-064 C1	EUDAMED	Class I	Active
Be White	BW24V-026 C2	EUDAMED	Class I	Active
Optical frame and sunglasses	Jade C6	EUDAMED	Class I	Active
Be White	BW25S-004 C4	EUDAMED	Class I	Active
Be White	BW24V-016 C2	EUDAMED	Class I	Active
Be White	Theo C6	EUDAMED	Class I	Active
PC anti blue presbyopic glasses	2	EUDAMED	Class I	Active
Be White	Aira C4	EUDAMED	Class I	Active
Be White	Jade C3	EUDAMED	Class I	Active
Be White	Theo C4	EUDAMED	Class I	Active
Be White	BW24S-058 C2	EUDAMED	Class I	Active
Ma	RETRO	EUDAMED	Class I	Active
Optical frame and sunglasses	Yara C1	EUDAMED	Class I	Active
Be White	Maya C2	EUDAMED	Class I	Active
Be White	BW24S-061 C2	EUDAMED	Class I	Active
Pharmactiv	CLASSIQUE	EUDAMED	Class I	Active
Be White	Aira C5	EUDAMED	Class I	Active
Be White	Dora C5	EUDAMED	Class I	Active
Be White	Cleo C2	EUDAMED	Class I	Active
Be White	Max C3	EUDAMED	Class I	Active
Be White	BW24V-005 C2	EUDAMED	Class I	Active
Pharmactiv	CLASSIQUE	EUDAMED	Class I	Active
Be White	BW24V-058 C4	EUDAMED	Class I	Active
Be White	BW24S-001 C4	EUDAMED	Class I	Active

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