Question 1

What types of medical devices does Wenzhou Banana Eyeware Co., Ltd. manufacture?

Accepted Answer

Wenzhou Banana Eyeware Co., Ltd. specializes in optical frames intended for prescription eyewear. These frames serve as the structural component for corrective lenses, supporting various designs including standard and customizable styles to fit different prescription needs.

Question 2

Where is Wenzhou Banana Eyeware Co., Ltd. based?

Accepted Answer

The company is headquartered in China. This geographical location influences its regulatory compliance and manufacturing operations, particularly for devices intended for markets with specific requirements.

Question 3

How are the devices manufactured by Wenzhou Banana Eyeware Co., Ltd. classified under EU regulations?

Accepted Answer

The optical frames produced by Wenzhou Banana Eyeware Co., Ltd. fall under Class I classification in the EU. This classification is typically assigned to low-risk devices, such as frames for eyewear, which pose minimal risk to users when used as intended.

Question 4

Are the devices from Wenzhou Banana Eyeware Co., Ltd. listed in any regulatory registries?

Accepted Answer

Yes, the company’s devices are listed in the EUDAMED registry. This database is maintained by the European Union to track medical devices that have undergone conformity assessment procedures, ensuring transparency and traceability for authorized products.

Device	Model / Reference	Registries	Class	Status
Optical Frames	CRINOLINE BK	EUDAMED	Class I	Active
Optical Frames	VELVETBLSK	EUDAMED	Class I	Active
Optical Frames	TULLE CROR	EUDAMED	Class I	Active
Optical Frames	VELVETGRPK	EUDAMED	Class I	Active
Optical Frames	BATISTE HVCR	EUDAMED	Class I	Active
Optical Frames	VELOUR HVCR	EUDAMED	Class I	Active
Optical Frames	DENIMICOR	EUDAMED	Class I	Active
Optical Frames	TULLE GYSL	EUDAMED	Class I	Active
Optical Frames	SILKGRBL	EUDAMED	Class I	Active
Optical Frames	SILKHVCR	EUDAMED	Class I	Active
optical frames	PLUSH HV	EUDAMED	Class I	Active
Optical Frames	DENIMBK	EUDAMED	Class I	Active
Optical Frames	LEATHERHVCR	EUDAMED	Class I	Active
optical frames	CANVAS BL	EUDAMED	Class I	Active
Optical Frames	DAMASK GYGO	EUDAMED	Class I	Active
optical frames	TULLE GR	EUDAMED	Class I	Active
optical frames	LUSTRING GY	EUDAMED	Class I	Active
Optical Frames	TULLE HVCR	EUDAMED	Class I	Active
Optical Frames	BALDACHINHVGR	EUDAMED	Class I	Active
06977354170168	FLANNELGR	EUDAMED	Class I	Active
Optical Frames	LEATHERHO	EUDAMED	Class I	Active
Optical Frames	CHIFFONBKPK	EUDAMED	Class I	Active
Optical Frames	SILKBLPK	EUDAMED	Class I	Active
optical frames	BURLAP BK	EUDAMED	Class I	Active
Optical Frames	POPLIN PRGR	EUDAMED	Class I	Active
Optical Frames	COTTONGROR	EUDAMED	Class I	Active
optical frames	PLUSH GR	EUDAMED	Class I	Active
Optical Frames	CORDUROY MCPK	EUDAMED	Class I	Active
Optical Frames	LINENBKWH	EUDAMED	Class I	Active
Optical Frames	WOOLGRCR	EUDAMED	Class I	Active
optical frames	PLUSH GY	EUDAMED	Class I	Active
Optical Frames	BALDACHINGY	EUDAMED	Class I	Active
Optical Frames	WOOLHVYL	EUDAMED	Class I	Active
Optical Frames	COTTONBYPK	EUDAMED	Class I	Active
Optical Frames	DAMASK BKSL	EUDAMED	Class I	Active
optical frames	CANVAS GR	EUDAMED	Class I	Active
optical frames	CRINOLINE GR	EUDAMED	Class I	Active
Optical Frames	POPLIN RDBG	EUDAMED	Class I	Active
Optical Frames	SATINGR	EUDAMED	Class I	Active
optical frames	BURLAP BL	EUDAMED	Class I	Active
Optical Frames	SATINHVCR	EUDAMED	Class I	Active
optical frames	LUSTRING GR	EUDAMED	Class I	Active
Optical Frames	SATINBK	EUDAMED	Class I	Active
optical frames	CRINOLINE BK	EUDAMED	Class I	Active
Optical Frames	LINENBKCR	EUDAMED	Class I	Active
Optical Frames	FLANNELHVCR	EUDAMED	Class I	Active
optical frames	VELOUR 2.0 BL	EUDAMED	Class I	Active
Optical Frames	POPLIN GYSL	EUDAMED	Class I	Active
Optical Frames	VELVETHVCR	EUDAMED	Class I	Active
Optical Frames	MOLESKIN GRSL	EUDAMED	Class I	Active

WENZHOU BANANA EYEWEAR CO., LTD.

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