Question 1

What types of medical devices does Hubei Guarddent Medical Technology Co., Ltd manufacture?

Accepted Answer

Hubei Guarddent Medical Technology Co., Ltd specializes in single-use dental devices. Their portfolio includes dental impression trays, articulating paper, sterilization pouches, barrier sleeves, disposable prophy brushes, prophy cups, mixing tips, and dental bibs. These products are designed for one-time clinical use to maintain hygiene and infection control during dental procedures.

Question 2

Where is Hubei Guarddent Medical Technology Co., Ltd based?

Accepted Answer

The company is headquartered in China. While its exact location within the country is not specified, its primary focus is on manufacturing dental devices tailored for global hygiene and infection control standards.

Question 3

Which regulatory registries list Hubei Guarddent Medical Technology Co., Ltd’s devices?

Accepted Answer

The company’s devices are registered in the EU’s eudamed database, which is the official European Union registry for medical devices. This registration is required for transparency and traceability of devices marketed within the EU.

Question 4

How are Hubei Guarddent Medical Technology Co., Ltd’s devices classified under medical device regulations?

Accepted Answer

All of the company’s listed devices fall under Class I classification. This classification typically applies to low-risk devices, such as single-use dental instruments and disposable accessories, which pose minimal risk to patients and users when used as intended.

Device	Model / Reference	Registries	Class	Status
Face Mask	LEVEL 3	EUDAMED	Class I	Active
Sterilization Pouches	Self-Sealing Sterilization Pouch	EUDAMED	Class I	Active
Fluoride Foam Trays	Dual Arch	EUDAMED	Class I	Active
Disposable Prophy Brush	Latch	EUDAMED	Class I	Active
Dental Mirror	Stainless Steel Dental Mirror	EUDAMED	Class I	Active
Disposable Prophy Brush	Latch	EUDAMED	Class I	Active
Barrier Sleeves	Curing Light Cover	EUDAMED	Class I	Active
Disposable Prophy Cup	Latch	EUDAMED	Class I	Active
Barrier Sleeves	X-Ray Film Cover	EUDAMED	Class I	Active
Dental Mirror	Autoclavable Oral Mirror	EUDAMED	Class I	Active
Disposable Prophy Brush	Screw-in	EUDAMED	Class I	Active
Mixing Accessories	Mixing Wells	EUDAMED	Class I	Active
Barrier Sleeves	X-Ray Sensor Cover	EUDAMED	Class I	Active
Dental Mirror	Micro Dental Mirror	EUDAMED	Class I	Active
Face Mask	Type I	EUDAMED	Class I	Active
Impression Trays	Autoclavable	EUDAMED	Class I	Active
Dental Mirror	Dental Hand Mirror	EUDAMED	Class I	Active
Mixing Tips	Disposable	EUDAMED	Class I	Active
Dental bibs	13"x18"	EUDAMED	Class I	Active
Dental bibs	13"x18"	EUDAMED	Class I	Active
Dental Wedges	Wooden Wedges	EUDAMED	Class I	Active
Disposable Prophy Cup	Latch	EUDAMED	Class I	Active
Articulating Paper	Straight Shape	EUDAMED	Class I	Active
Dental Wedges	Resin Interdental Wedges	EUDAMED	Class I	Active
Dispenser Gun	Composite Tip Gun	EUDAMED	Class I	Active
Barrier Film	4“x6"	EUDAMED	Class I	Active
Disposable Prophy Cup	Latch	EUDAMED	Class I	Active
Barrier Sleeves	Barrier Envelopes	EUDAMED	Class I	Active
Barrier Sleeves	X-Ray Sensor Cover	EUDAMED	Class I	Active
Face Mask	LEVEL 2	EUDAMED	Class I	Active
Face Mask	Type II	EUDAMED	Class I	Active
Disposable Prophy Cup	Latch	EUDAMED	Class I	Active
Face Mask	Type IIR	EUDAMED	Class I	Active
Disposable Prophy Angle	DISPOSABLE	EUDAMED	Class I	Active
Disposable Prophy Angle	DISPOSABLE	EUDAMED	Class I	Active
Suction Tips	High Volume HVE Tips	EUDAMED	Class I	Active
Dental Mirror	Dental Hand Mirror	EUDAMED	Class I	Active
Dental Wedges	Plastic Wedges	EUDAMED	Class I	Active
Suction Tips	Removable Tips	EUDAMED	Class I	Active
Mixing Accessories	Mixing Bowl	EUDAMED	Class I	Active
Face Mask	Type IIR	EUDAMED	Class I	Active
Mixing Tips	Disposable	EUDAMED	Class I	Active
Barrier Sleeves	Bite Block Cover	EUDAMED	Class I	Active
Disposable Prophy Cup	Latch	EUDAMED	Class I	Active
Mixing Accessories	Mixing Wells	EUDAMED	Class I	Active
Three Way Syringe Tips	Disposable	EUDAMED	Class I	Active
Barrier Sleeves	Full Chair Cover	EUDAMED	Class I	Active
Barrier Sleeves	headrest covers	EUDAMED	Class I	Active
Disposable Prophy Brush	Screw-in	EUDAMED	Class I	Active
Disposable Prophy Angle	DISPOSABLE	EUDAMED	Class I	Active

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