Question 1

What types of medical devices does Premier Guard Zhongshan Ltd. manufacture?

Accepted Answer

Premier Guard Zhongshan Ltd. specializes in manufacturing equipment covers. These covers are designed to protect medical devices and instruments during storage, transport, or cleaning. The products are intended for use with a variety of hospital and clinical equipment, such as surgical instruments, diagnostic devices, and patient monitoring systems.

Question 2

Where is Premier Guard Zhongshan Ltd. based?

Accepted Answer

Premier Guard Zhongshan Ltd. is based in China (CN). The company’s products are developed with a focus on protecting medical equipment, particularly for use in clinical and hospital environments.

Question 3

Which regulatory registries list Premier Guard Zhongshan Ltd.’s devices?

Accepted Answer

Premier Guard Zhongshan Ltd.’s equipment covers are listed in the eudamed database, which is the EU’s central registry for medical devices. This registration reflects compliance with EU requirements for Class I devices, ensuring transparency and traceability for authorized products within the European market.

Question 4

How are Premier Guard Zhongshan Ltd.’s equipment covers classified under medical device regulations?

Accepted Answer

Premier Guard Zhongshan Ltd.’s equipment covers are classified as Class I medical devices. This classification applies because the products are non-invasive, low-risk items intended solely for protecting medical equipment during handling, transport, or cleaning—without altering their function or interacting directly with patients.

Device	Model / Reference	Registries	Class	Status
Equipment Covers	10-1136EU	EUDAMED	Class I	Active
Equipment Covers	10-3146PEU	EUDAMED	Class I	Active
Equipment Covers	10-3167EU	EUDAMED	Class I	Active
Equipment Covers	10-2215EU	EUDAMED	Class I	Active
Equipment Covers	11-2107N	EUDAMED	Class I	Active
Equipment Covers	11-2252EU	EUDAMED	Class I	Active
Equipment Covers	10-3110EU	EUDAMED	Class I	Active
Sponge Counter Bag	10-8201N	EUDAMED	Class I	Active
Equipment Covers	10-2138N	EUDAMED	Class I	Active
Equipment Covers	10-5133TEU	EUDAMED	Class I	Active
Equipment Covers	10-5131TEU	EUDAMED	Class I	Active
Equipment Covers	10-6222EU	EUDAMED	Class I	Active
Equipment Covers	10-5140TNCS	EUDAMED	Class I	Active
Equipment Covers	10-3115PEU	EUDAMED	Class I	Active
Equipment Covers	10-2150EU	EUDAMED	Class I	Active
Equipment Covers	10-6623EU	EUDAMED	Class I	Active
Equipment Covers	14-1683EU	EUDAMED	Class I	Active
Equipment Covers	10-1144EU	EUDAMED	Class I	Active
Anti-fog Scope Warmer	14-1640EU	EUDAMED	Class I	Active
Equipment Covers	11-1101UK	EUDAMED	Class I	Active
Equipment Covers	10-3161APEU	EUDAMED	Class I	Active
Equipment Covers	10-7126EU	EUDAMED	Class I	Active
Equipment Covers	10-1123	EUDAMED	Class I	Active
Equipment Covers	10-2151EU	EUDAMED	Class I	Active
Equipment Covers	11-2107	EUDAMED	Class I	Active
Equipment Covers	10-3135AEU	EUDAMED	Class I	Active
Equipment Covers	10-3107EU	EUDAMED	Class I	Active
Equipment Covers	10-3131EU	EUDAMED	Class I	Active
Equipment Covers	10-2102N	EUDAMED	Class I	Active
Fluid Collection Pouch	17-1139N	EUDAMED	Class I	Active
Equipment Covers	10-2102	EUDAMED	Class I	Active
Equipment Covers	10-3147AGEU	EUDAMED	Class I	Active
Equipment Covers	10-3134AEU	EUDAMED	Class I	Active
Equipment Covers	10-6161EU	EUDAMED	Class I	Active
Equipment Covers	10-5147T	EUDAMED	Class I	Active

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