Question 1

What types of medical devices does Changzhou Hualian Health Dressing Co., Ltd primarily manufacture?

Accepted Answer

Changzhou Hualian Health Dressing Co., Ltd specializes in adhesive bandages and related products. Their portfolio includes microporous tape, zinc oxide tape, cohesive support bandages, multi-purpose surgical skin adhesive tapes, rolls of paper tape, perforated cotton surgical tape, sterile adhesive dressings with central gauze, and various plaster options. These products are designed for wound care, skin adhesion, and support applications.

Question 2

Where is Changzhou Hualian Health Dressing Co., Ltd based?

Accepted Answer

The company is headquartered in China. This geographic location influences its regulatory compliance requirements, particularly for devices marketed globally, as it must adhere to both domestic and international standards.

Question 3

Which regulatory registries list devices manufactured by Changzhou Hualian Health Dressing Co., Ltd?

Accepted Answer

The company’s devices are listed in the EU’s EUDAMED database and the FDA’s Unique Device Identifier (UDI) system. These registries ensure transparency and traceability of medical devices in their respective markets, helping regulators and healthcare providers verify product details.

Question 4

How are the devices produced by Changzhou Hualian Health Dressing Co., Ltd classified under regulatory frameworks?

Accepted Answer

All devices manufactured by Changzhou Hualian Health Dressing Co., Ltd fall under Class I classification. This classification applies to low-risk medical devices like adhesive bandages, which typically require minimal regulatory oversight compared to higher-risk categories. The classification ensures compliance with basic safety and performance requirements.

Device	Model / Reference	Registries	Class	Status
Adhesive Nonwoven Dressings	061205	EUDAMED	Class I	Active
Microporous Surgical Tape	135320	EUDAMED	Class I	Active
Adhesive Plasters	080614	EUDAMED	Class I	Active
Microporous Tape	7759673	EUDAMEDFDA UDI	Class I	Active
Adhesive Plasters	061501	EUDAMED	Class I	Active
Adhesive Plaster Roll	400014	EUDAMED	Class I	Active
Microporeux hypollergenique	3401060111793	EUDAMED	Class I	Active
Adhesive Medica	/	EUDAMED	Class I	Active
Plaster	WZWZ002	EUDAMED	Class I	Active
Nonwoven Iv Wound Dressing	SUIVD005	EUDAMED	Class I	Active
Medical tape	WZWZ004	EUDAMED	Class I	Active
Protective Face Masks	1157795	EUDAMED	Class I	Active
Pansement adhésif stérile avec compresse centrale	061311	EUDAMED	Class I	Active
Non-woven tape	/	EUDAMED	Class I	Active
Adhesive Plaster	/	EUDAMED	Class I	Active
Adhesive Dressing	69417626010UW	EUDAMED	Class I	Active
Pansement adhésif stérile avec compresse centrale	061314	EUDAMED	Class I	Active
Protective Dressings	8911355	EUDAMED	Class I	Active
Microporous surgical tape	135312	EUDAMED	Class I	Active
Sparadrap perforé coton	060930	EUDAMED	Class I	Active
Adhesive Plasters	061105	EUDAMED	Class I	Active
Medical Tape	/	EUDAMED	Class I	Active
Adhesive Tape	B025-243	EUDAMED	Class I	Active
Sterile Adhesive Wound Dressings	jxwes57-UAB	EUDAMED	Class I	Active
Adhesive Plasters	080612	EUDAMED	Class I	Active
Medical Adhesive Tape Perforated	2101125	EUDAMED	Class I	Active
Zinc Oxide Adhesive Plaster	060932	EUDAMED	Class I	Active
Pansement adhésif stérile avec compresse centrale	061309	EUDAMED	Class I	Active
Micro-perforated Surgical Tape	135398	EUDAMED	Class I	Active
Silk tape	061001	EUDAMED	Class I	Active
Non-woven tape	061003	EUDAMED	Class I	Active
Medical Tape	061007	EUDAMED	Class I	Active
Pansement adhésif stérile avec compresse centrale	061310	EUDAMED	Class I	Active
Stretch Fabric Strapping	9095837	EUDAMED	Class I	Active
Pleister strips	1200212	EUDAMED	Class I	Active
Nonwoven Plaster Roll	400071	EUDAMED	Class I	Active
Wound dressing	061008	EUDAMED	Class I	Active
Wound Dressings	8911339	EUDAMED	Class I	Active
Eilandpleister	1200217	EUDAMED	Class I	Active
Micro-perforated surgical tape	135395	EUDAMED	Class I	Active
Microporous Surgical Tape	135321	EUDAMED	Class I	Active
Medical Adhesive Tape Perforated	2101452	EUDAMED	Class I	Active
Microporous surgical tape	135326	EUDAMED	Class I	Active
Sterile adhesive wound dressing	/	EUDAMED	Class I	Active
Pansement adhésif stérile avec compresse centrale	061313	EUDAMED	Class I	Active
Sparadrap non tissé multiextensible	061010	EUDAMED	Class I	Active
Rolls of paper tape	060923	EUDAMED	Class I	Active
non woven plaster roll	PS400071	EUDAMED	Class I	Active
Wound dressing	060941	EUDAMED	Class I	Active

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