Question 1

What types of medical devices does Tianjin Empecs Medical Device Co., Ltd. manufacture?

Accepted Answer

Tianjin Empecs Medical Device Co., Ltd. specializes in in vitro diagnostic (IVD) devices for glucose monitoring, primarily designed for home use. Their product range includes blood glucose meters (such as the CareTouch series and Medisign GH8x systems), reagent strips for testing, control solutions for quality assurance, and Bluetooth-enabled meters like the Medisign MM1000 BT and Smart Diabetes Bluetooth Pro. These devices are intended for measuring glucose levels in blood, supporting both individual and multi-patient monitoring.

Question 2

Where is Tianjin Empecs Medical Device Co., Ltd. based, and what regulatory pathways do their devices follow?

Accepted Answer

Tianjin Empecs Medical Device Co., Ltd. is based in the United States. Their devices are regulated under the US FDA system, with authorisation records maintained in the FDA 510(k) and UDI (Unique Device Identification) databases. This reflects their classification as either Class I or Class II devices, which are subject to varying levels of regulatory oversight depending on their risk profile and intended use.

Question 3

Which regulatory registries list the devices manufactured by Tianjin Empecs Medical Device Co., Ltd.?

Accepted Answer

The devices produced by Tianjin Empecs Medical Device Co., Ltd. are listed in the FDA’s 510(k) premarket notification database and the FDA’s UDI system. These registries track the regulatory authorisation status of medical devices in the United States, ensuring transparency about their classification and compliance with applicable regulations. The 510(k) pathway is commonly used for devices that are substantially equivalent to legally marketed predicates, while the UDI system provides a unique identifier for each device to improve tracking and traceability.

Question 4

How are the glucose monitoring devices from Tianjin Empecs Medical Device Co., Ltd. classified under US regulations?

Accepted Answer

The glucose monitoring devices from Tianjin Empecs Medical Device Co., Ltd. are classified under the US FDA’s regulatory framework as either Class I or Class II. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure their safety and effectiveness. The classification is determined based on factors like the device’s intended use, potential risks, and the degree of regulatory oversight needed to mitigate those risks.

Device	Model / Reference	Registries	Class	Status
Laryngeal Masks	LMA-V Cuff-3.0	EUDAMED	Class IIa	Active
Tracheostomy Tubes	TT-P3-60	EUDAMED	Class IIa	Active
Laryngeal Masks	LM-V Cuff-3.0	EUDAMED	Class IIa	Active
Laryngeal Masks	LMA-V Cuff-4.0	EUDAMED	Class IIa	Active
Endotracheal Tubes	ETT-B22-90	EUDAMED	Class IIa	Active
Laryngeal Masks	LM-V Cuff-1.0	EUDAMED	Class IIa	Active
Laryngeal Masks	LM-V Cuff-2.0	EUDAMED	Class IIa	Active
Laryngeal Masks	LM-V Cuff-4.0	EUDAMED	Class IIa	Active
Double-lumen Endobronchial Tubes	DLT-R11-37	EUDAMED	Class IIa	Active
Laryngeal Masks	LM-V Cuff-0.5	EUDAMED	Class IIa	Active
Laryngeal Masks	LM-V Cuff-5.0	EUDAMED	Class IIa	Active
Double-lumen Endobronchial Tubes	DLT-L10-41	EUDAMED	Class IIa	Active
Nasopharyngeal Airways	NF203	EUDAMED	Class I	Active
Nasopharyngeal Airways	NF305	EUDAMED	Class I	Active
Laryngeal Masks	LMA-V Cuff-5.0	EUDAMED	Class IIa	Active
Laryngeal Masks	LM-V Cuff-0.0	EUDAMED	Class IIa	Active
Stylets	ESA10	EUDAMED	Class I	Active
Double-lumen Endobronchial Tubes	DLT-R10-39	EUDAMED	Class IIa	Active
Double-lumen Endobronchial Tubes	DLT-L11-39	EUDAMED	Class IIa	Active
Double-lumen Endobronchial Tubes	DLT-R10-41	EUDAMED	Class IIa	Active
Double-lumen Endobronchial Tubes	DLT-L10-26	EUDAMED	Class IIa	Active
Double-lumen Endobronchial Tubes	DLT-L10-35	EUDAMED	Class IIa	Active
Nasopharyngeal Airways	NF309	EUDAMED	Class I	Active
Nasopharyngeal Airways	NF143	EUDAMED	Class I	Active
Laryngeal Masks	LM-V Cuff-1.5	EUDAMED	Class IIa	Active
Stylets	ESA08	EUDAMED	Class I	Active
Stylets	ESA06	EUDAMED	Class I	Active
Tracheostomy Tubes	TT-P1-30	EUDAMED	Class IIa	Active
Stylets	ESA14	EUDAMED	Class I	Active
Nasopharyngeal Airways	NF103	EUDAMED	Class I	Active
Nasopharyngeal Airways	NF114	EUDAMED	Class I	Active
Laryngeal Masks	LM-PC-1.0	EUDAMED	Class IIa	Active
Medis	NF207	EUDAMEDFDA UDI	Class I	Active
CareTouch	CTMK	FDA UDI	Class II	Active
Medis	NF407	FDA UDI	Class I	Active
Medis	NF208	EUDAMEDFDA UDI	Class I	Active
Medis	ETT-X22-60	FDA UDI	Class II	Active
Medis	NF206	EUDAMEDFDA UDI	Class I	Active
Medis	ETT-P22-65	FDA UDI	Class II	Active
Medis	ETT-J22-90	FDA UDI	Class II	Active
CareTouch	CTMK150	FDA UDI	Class II	Active
Medis	NF109	EUDAMEDFDA UDI	Class I	Active
Medis	NF405	FDA UDI	Class I	Active
Medis	NF418	FDA UDI	Class I	Active
CareTouch	CTMK50	FDA UDI	Class II	Active
Medis	NF404	FDA UDI	Class I	Active
Medis	NF417	FDA UDI	Class I	Active
Medis	NF406	FDA UDI	Class I	Active
Medis	NF108	EUDAMEDFDA UDI	Class I	Active
CareTouch	CT100	FDA UDI	Class II	Active

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