Question 1

What types of medical devices does RGH Enterprises manufacture?

Accepted Answer

RGH Enterprises specializes in wound care and medical adhesive products. Their portfolio includes non-silicone skin adhesive tapes, exudate-absorbent dressings (both antimicrobial and non-antimicrobial), hydrophilic-gel dressings, single-use blood lancets, adhesive bandages, non-woven gauze pads, and airway suction catheters. These devices are designed for clinical use to support wound management, patient adhesion, and airway maintenance.

Question 2

Where is RGH Enterprises based?

Accepted Answer

RGH Enterprises is based in the United States. The company’s headquarters and operations are located within the country, aligning with its regulatory and manufacturing focus.

Question 3

Which regulatory registries list RGH Enterprises’ devices?

Accepted Answer

RGH Enterprises’ devices are listed in the FDA’s Unique Device Identification (UDI) system. This registry ensures traceability and transparency for each device, allowing healthcare providers and regulators to identify and track specific products authorized for use in the U.S.

Question 4

How are RGH Enterprises’ devices classified under FDA regulations?

Accepted Answer

RGH Enterprises’ devices fall under three FDA classification categories: Class I (generally low-risk devices requiring minimal regulation), Class II (devices with moderate risk requiring special controls), and unclassified (U) devices (those not yet assigned a risk level). Classification depends on factors like intended use, potential risks, and clinical impact, ensuring appropriate oversight for each product.

Device	Model / Reference	Registries	Class	Status
Cardinal Health Essentials	ZTPA03A	FDA UDI	Class I	Active
Cardinal Health Essentials	ZTPA01AT	FDA UDI	Class I	Active
Cardinal Health Essentials	ZDTF812	FDA UDI	Class I	Active
Cardinal Health Essentials	ZDSF44B	FDA UDI	Class I	Active
Cardinal Health Essentials	ZTSC02	FDA UDI	Class I	Active
Cardinal Health Essentials	ZPL12000	FDA UDI	Class II	Active
Onesource	ZPL10030OS	FDA UDI	Class II	Active
Cardinal Health Essentials	ZTPA02AT	FDA UDI	Class I	Active
Reliamed	ZGC44	FDA UDI	Class I	Active
Cardinal Health Essentials	ZDHC44B	FDA UDI	Class I	Active
Cardinal Health Essentials	ZTDR06	FDA UDI	Class I	Active
Cardinal Health Essentials	ZTCL05A	FDA UDI	Class I	Active
Reliamed	ZGB44	FDA UDI	Class I	Active
Cardinal Health Essentials	ZDF44	FDA UDI	Class I	Active
Cardinal Health Essentials	ZRSC10S	FDA UDI	Class I	Active
Cardinal Health Essentials	ZRSCK10	FDA UDI	Class I	Active
Reliamed	ZGB48	FDA UDI	Class I	Active
Cardinal Health Essentials	ZRSC12S	FDA UDI	Class I	Active
Cardinal Health Essentials	ZPL20028A	FDA UDI	Class II	Active
Cardinal Health Essentials	ZRSCK14	FDA UDI	Class I	Active
Cardinal Health Essentials	ZDTF410	FDA UDI	Class I	Active
Reliamed	ZGFB44	FDA UDI	Class I	Active
Cardinal Health Essentials	ZRSCK8	FDA UDI	Class I	Active
Cardinal Health Essentials	ZRSCK16	FDA UDI	Class I	Active
Cardinal Health Essentials	ZDTF238234	FDA UDI	Class I	Active
Cardinal Health Essentials	ZTSC06	FDA UDI	Class I	Active
Reliamed	ZGB235	FDA UDI	Class I	Active
Cardinal Health Essentials	ZTPL02A	FDA UDI	Class I	Active
Cardinal Health Essentials	ZDHC67SB	FDA UDI	Class I	Active
Cardinal Health	ZPL10030PC	FDA UDI	Class II	Active
Cardinal Health Essentials	ZTCL01A	FDA UDI	Class I	Active
Cardinal Health Essentials	ZPL30023S	FDA UDI	Class II	Active
Reliamed	ZGC66	FDA UDI	Class I	Active
Cardinal Health Essentials	ZTSC03	FDA UDI	Class I	Active
Cardinal Health Essentials	ZDF55B	FDA UDI	Class I	Active
Cardinal Health Essentials	ZDHC22B	FDA UDI	Class I	Active
Cardinal Health Essentials	ZDF33B	FDA UDI	Class I	Active

RGH ENTERPRISES

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