Question 1

What types of medical devices does ClearPoint Medical Inc. manufacture?

Accepted Answer

ClearPoint Medical Inc. specializes in undergarments and supportive garments, including bras, body suits, compression vests, waistbands, and neck wraps. These devices are designed for general comfort, support, and aesthetic shaping, with variations in size, color, and material. Examples include molded cup bras, surgical vests, and compression garments.

Question 2

Where is ClearPoint Medical Inc. based?

Accepted Answer

ClearPoint Medical Inc. is headquartered in Canada. The company operates from this location while developing and manufacturing its range of supportive and undergarment devices.

Question 3

Which regulatory registries list ClearPoint Medical Inc.’s devices?

Accepted Answer

ClearPoint Medical Inc.’s devices are listed in the EUDAMED database, which is the European Union’s medical device registry. This listing ensures transparency and compliance with EU regulatory requirements for Class I devices.

Question 4

How are ClearPoint Medical Inc.’s devices classified under medical device regulations?

Accepted Answer

All devices manufactured by ClearPoint Medical Inc. fall under Class I regulatory classification. This classification applies to low-risk devices like undergarments and supportive garments, which pose minimal risk to patients and users.

Question 5

Why are ClearPoint Medical Inc.’s products considered medical devices?

Accepted Answer

ClearPoint Medical Inc.’s garments, such as compression vests and surgical vests, are classified as medical devices because they are intended to support or protect the body in a medical context—such as post-operative recovery or surgical assistance. Even general comfort and shaping garments may qualify if they serve a therapeutic or supportive purpose.

Device	Model / Reference	Registries	Class	Status
Zippered BBL Shapewear Black XX-Large	75201XX00	EUDAMED	Class I	Active
Premium Long Vest with Zipper Black 3X-Large	786013X00	EUDAMED	Class I	Active
High Back Zippered Brief Black Medium	72001ME00	EUDAMED	Class I	Active
Abdominal Girdle Black X-Large	47201XL00	EUDAMED	Class I	Active
Zippered Molded Cup Bra Beige 38-B	7110238B	EUDAMED	Class I	Active
Adjustable Molded Cup Support Bra Beige 30-C	7100230C	EUDAMED	Class I	Active
Adjustable Molded Cup Support Bra Black 34-C	7100134C	EUDAMED	Class I	Active
Short Vest (Women) Beige Medium	28802ME00	EUDAMED	Class I	Active
Compression Vest (Men) Beige Medium	28702ME00	EUDAMED	Class I	Active
Microfiber Above-Knee Shapewear Beige Medium	72202ME00	EUDAMED	Class I	Active
Above-Knee Body Suit Black Large	83001LG00	EUDAMED	Class I	Active
High Back Zipperless Brief Black Large	71901LG00	EUDAMED	Class I	Active
Male Bodysuit Black Large	47001LG00	EUDAMED	Class I	Active
Premium Long Vest with Zipper Black Small	78601SM00	EUDAMED	Class I	Active
Above Knee High Back Body Girdle Beige XX-Large	74002XXL0	EUDAMED	Class I	Active
Zippered Molded Cup Bra Black 36-D	7110136D	EUDAMED	Class I	Active
Adjustable Molded Cup Support Bra Black 30-B	7100130B	EUDAMED	Class I	Active
Waistband Above Knee Beige Medium	44002ME00	EUDAMED	Class I	Active
Classic Below-Knee High Back Black Full Body Shapewear X-Small	36101XS00	EUDAMED	Class I	Active
Classic Comfort Bra Beige Size 40 (Pkg 2)	218024000	EUDAMED	Class I	Active
Zipplerless BBL Capri Black Large	72801LG00	EUDAMED	Class I	Active
Cotton Adjustable Bra Black Size 34	275013400	EUDAMED	Class I	Active
Adjustable Molded Cup Support Bra Beige 48-D	7100248D	EUDAMED	Class I	Active
Facial Wrap 75cm (Pkg 12)	228000012	EUDAMED	Class I	Active
Below-Knee Beige Full Body Girdle Small	36002SM00	EUDAMED	Class I	Active
Capri BBL Beige X-Small	75102XS00	EUDAMED	Class I	Active
Below Knee High Back Black Medium	78001ME00	EUDAMED	Class I	Active
Zippered Molded Cup Bra Black 34-B	7110134B	EUDAMED	Class I	Active
Medical Comfort Bra Black Size 46	217014600	EUDAMED	Class I	Active
Open Bust Arm Sleeve Black Small	73701SM00	EUDAMED	Class I	Active
High Back Zippered Brief Black XX-Large	72001XXL0	EUDAMED	Class I	Active
Above-Knee Body Suit Beige X-Small	83002XS00	EUDAMED	Class I	Active
Zipperless Microfiber Above Knee Shapewear Beige Medium	72402ME00	EUDAMED	Class I	Active
Above-Knee High Back Body Girdle Black Large	74001LG00	EUDAMED	Class I	Active
Capri BBL Black X-Large	75101XL00	EUDAMED	Class I	Active
Waistband Below Knee Beige 3X-Large	460023X00	EUDAMED	Class I	Active
Adjustable Comfort Bra Beige Size 40	216024000	EUDAMED	Class I	Active
Cotton Adjustable Bra Black Size 44	275014400	EUDAMED	Class I	Active
Above-Knee Beige Body Girdle X-Small	34002XS00	EUDAMED	Class I	Active
Medical Comfort Bra Beige Size 32	217023200	EUDAMED	Class I	Active

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