Question 1

What types of medical devices does Kosma-Kare Canada Inc manufacture?

Accepted Answer

Kosma-Kare Canada Inc produces two primary types of medical devices: waterproof skin adhesive tapes and cotton pleats. The adhesive tapes are designed for medical and personal care applications, ensuring durability and secure adhesion even when exposed to moisture. The cotton pleats are used in wound management to provide support and absorbency under dressings, helping maintain a clean and protected wound environment.

Question 2

Where is Kosma-Kare Canada Inc based, and does this affect its regulatory standing?

Accepted Answer

Kosma-Kare Canada Inc is based in the United States. The company’s location influences its regulatory obligations, as it must comply with U.S. regulations like those enforced by the FDA. However, regulatory standing is determined by individual devices, not the company itself, and their products fall under the FDA’s Unique Device Identifier (UDI) database for tracking and transparency.

Question 3

Which regulatory registries list Kosma-Kare Canada Inc’s devices?

Accepted Answer

Kosma-Kare Canada Inc’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and compliance tracking for Class I medical devices, including their waterproof adhesive tapes and cotton pleats, by assigning a standardized identifier to each product.

Question 4

How are Kosma-Kare Canada Inc’s devices classified under medical device regulations?

Accepted Answer

All of Kosma-Kare Canada Inc’s devices are classified as Class I medical devices. This classification applies to products posing minimal risk to patients, such as waterproof adhesive tapes and cotton pleats, which are generally considered low-risk and subject to fewer regulatory controls than higher-risk devices.

Device	Model / Reference	Registries	Class	Status
Kosma-Kare	KB-2288	FDA UDI	Class I	Active
Zino	5BZL2006	FDA UDI	Class I	Active
Zino	5TZ4003-5	FDA UDI	Class I	Active
Kosma-Kare	KC-2289	FDA UDI	Class I	Active
Kosma-Kare	J-2279	FDA UDI	Class I	Active
Kosma-Kare	J-2277	FDA UDI	Class I	Active
Zino	5BZC1012	FDA UDI	Class I	Active
Zino	5TZ1012-5	FDA UDI	Class I	Active
Zino	5BZC3001	FDA UDI	Class I	Active
Zino	5BZL0712	FDA UDI	Class I	Active
Zino	5BZL1506	FDA UDI	Class I	Active
Kosma-Kare	KB-2289	FDA UDI	Class I	Active
Zino	5TZ0524-5	FDA UDI	Class I	Active
Kosma-Kare	J-2288	FDA UDI	Class I	Active
Zino	5TZ0716-5	FDA UDI	Class I	Active
Zino	5BZL0518	FDA UDI	Class I	Active
Zino	5BZC0518	FDA UDI	Class I	Active
Pinc	OMAM111CS	FDA UDI	Class I	Active
Kosma-Kare	J-2281	FDA UDI	Class I	Active
Kosma-Kare	KC-2281	FDA UDI	Class I	Active
Kosma-Kare	KC-2288	FDA UDI	Class I	Active
Kosma-Kare	J-2278	FDA UDI	Class I	Active
Pinc	OMAM222CS	FDA UDI	Class I	Active
Zino	5BZC2006	FDA UDI	Class I	Active
Zino	5TZ2006-5	FDA UDI	Class I	Active
Pinc	OMAM55CS	FDA UDI	Class I	Active
Kosma-Kare	KC-2290	FDA UDI	Class I	Active
Zino	5TZ1508-5	FDA UDI	Class I	Active
Zino	5BZL4001	FDA UDI	Class I	Active
Zino	5BZL3001	FDA UDI	Class I	Active
Zino	5BZL0218	FDA UDI	Class I	Active
Zino	5BZL1012	FDA UDI	Class I	Active
Kosma-Kare	KC-2287	FDA UDI	Class I	Active
Kosma-Kare	KC-2292	FDA UDI	Class I	Active
Zino	5BZC1506	FDA UDI	Class I	Active

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