Question 1

What types of medical devices does Lohmann & Rauscher International GmbH & Co KG manufacture?

Accepted Answer

Lohmann & Rauscher International GmbH & Co KG specializes in wound care and related products. Their portfolio includes nonadherent wound dressings that absorb exudate without antimicrobial properties, such as synthetic polymer film dressings with adhesive backing and hydrophilic-gel variants. They also produce wound debridement tools, compression bandaging kits, fixation skin adhesive tapes, and ophthalmic sponges for delicate eye care applications. These devices are designed to support wound management and skin protection.

Question 2

Where is Lohmann & Rauscher International GmbH & Co KG based, and does it operate in the US?

Accepted Answer

Lohmann & Rauscher International GmbH & Co KG has a presence in the United States, where it operates in compliance with applicable domestic and international medical device regulations. While the company is headquartered in Germany, its US operations ensure it can meet regulatory requirements and serve the US market for its wound care and related products.

Question 3

Which regulatory registries or databases list the devices manufactured by Lohmann & Rauscher International GmbH & Co KG?

Accepted Answer

The devices produced by Lohmann & Rauscher International GmbH & Co KG are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the US, ensuring transparency and traceability for healthcare providers and regulators.

Question 4

How are the devices manufactured by Lohmann & Rauscher International GmbH & Co KG classified under FDA regulations?

Accepted Answer

The devices from Lohmann & Rauscher International GmbH & Co KG fall under two primary FDA classification categories: Class I and Class II. Class I devices are generally considered low-risk and subject to general controls, while Class II devices involve a higher level of risk and require special controls to ensure their safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body area it interacts with.

Question 5

What is the purpose of the wound debridement tools and compression bandaging kits produced by Lohmann & Rauscher International GmbH & Co KG?

Accepted Answer

The wound debridement tools are designed to remove necrotic tissue or debris from wounds, promoting healing by creating a clean environment for new tissue growth. Compression bandaging kits, on the other hand, are used to apply controlled pressure to wounds or limbs, which helps reduce swelling, improve circulation, and support the healing process—particularly for conditions like chronic venous insufficiency or lymphedema.

Device	Model / Reference	Registries	Class	Status
Vliwasorb	Wound Dressing	FDA UDI	Class I	Active
Debrisoft	Lolly	FDA UDI	Class I	Active
Vliwasorb	Pro 10x10cm	FDA UDI	Class I	Active
Vliwasorb	Wound Dressing	FDA UDI	Class I	Active
Suprasorb	F Protect 15 cm x 20 cm	FDA UDI	Class I	Active
Debrisoft	Pad 10x10cm	FDA UDI	Class I	Active
Suprasorb	F 20 x 30 cm	FDA UDI	Class I	Active
Suprasorb	P self-adhesive	FDA UDI	Class I	Active
Vliwasorb	Adhesive Wound Dressing	FDA UDI	Class I	Active
Suprasorb	P non adhesive	FDA UDI	Class I	Active
Suprasorb	F Protect 20 x 30 cm	FDA UDI	Class I	Active
Metalline	Wound Dressing 8x10cm	FDA UDI	Class I	Active
Debrisoft	Duo 10x10cm	FDA UDI	Class I	Active
Suprasorb	P non adhesive	FDA UDI	Class I	Active
Vliwasorb	Adhesive Wound Dressing	FDA UDI	Class I	Active
Suprasorb	P self-adhesive	FDA UDI	Class I	Active
Pro-ophta@	Ocular Sticks	FDA UDI	Class II	Active
Debrisoft	Duo 10x10cm	FDA UDI	Class I	Active
Suprasorb	F 5 x 7 cm	FDA UDI	Class I	Active
Varicex	Zinc Paste Bandage	FDA UDI	U	Unknown
Suprasorb	F Protect 10 cm x 12 cm	FDA UDI	Class I	Active
Suprasorb	F 10 cm x 25 cm	FDA UDI	Class I	Active
Suprasorb	A Wound Dressing 10 x 10 cm	FDA UDI	Class I	Active
Debrisoft	Pad 10x10cm	FDA UDI	Class I	Active
Suprasorb	F 10 cm x 20 cm	FDA UDI	Class I	Active
Suprasorb	F Protect 10 cm x 12 cm	FDA UDI	Class I	Active
Metalline	Drainage Pad 6x7cm	FDA UDI	Class I	Active
Vliwasorb	Pro 12,5x12,5cm	FDA UDI	Class I	Active
Debrisoft	Duo 13x20cm	FDA UDI	Class I	Active
Vliwasorb	Pro 22x22cm	FDA UDI	Class I	Active
Suprasorb	P sacrum self-adhesive	FDA UDI	Class I	Active
Suprasorb	F Protect 5 x 7 cm	FDA UDI	Class I	Active
Suprasorb	F 10 cm x 12 cm	FDA UDI	Class I	Active
Suprasorb	P self-adhesive	FDA UDI	Class I	Active
Vliwasorb	Adhesive Wound Dressing	FDA UDI	Class I	Active
Suprasorb	A Wound Dressing 10 x 12,5 cm	FDA UDI	Class I	Active
Metalline	Wound Dressing 10x12cm	FDA UDI	Class I	Active
Suprasorb	P non adhesive	FDA UDI	Class I	Active
Vliwasorb	Wound Dressing	FDA UDI	Class I	Active
Suprasorb	F Protect 10 cm x 25 cm	FDA UDI	Class I	Active
Debrisoft	Pad 13x20cm	FDA UDI	Class I	Active
Suprasorb	F Protect 5 x 7 cm	FDA UDI	Class I	Active
Vliwasorb	Wound Dressing self-adhesive	FDA UDI	Class I	Active
Silkafix	Adhesive tape 2,5cm x 5m	FDA UDI	Class I	Active
Rosidal	Sys	FDA UDI	Class I	Active
Suprasorb	A Rope 30cm /2g	FDA UDI	Class I	Active
Suprasorb	P non adhesive	FDA UDI	Class I	Active
Vliwasorb	Pro 22x32cm	FDA UDI	Class I	Active
Suprasorb	F 10 cm x 12 cm	FDA UDI	Class I	Active
Suprasorb	P non adhesive	FDA UDI	Class I	Active

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