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
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
Medis	NF409	FDA UDI	Class I	Active
Medis	NF105	EUDAMEDFDA UDI	Class I	Active
Medis	AC0100P	FDA UDI	Class II	Active
Medis	ETT-X22-80	FDA UDI	Class II	Active
Medis	NF408	FDA UDI	Class I	Active
Medis	NF107	EUDAMEDFDA UDI	Class I	Active
Medis	NF416	EUDAMEDFDA UDI	Class I	Active
CareTouch	CT2-3	FDA UDI	Class I	Active
Medis	ETT-P22-60	FDA UDI	Class II	Active
CareTouch	CT50	FDA UDI	Class II	Active
Medis	ETT-P22-70	FDA UDI	Class II	Active
Medis	ETT-X22-75	FDA UDI	Class II	Active
Medis	NF414	EUDAMEDFDA UDI	Class I	Active
Medis	ETT-X22-90	FDA UDI	Class II	Active
Medis	NF415	EUDAMEDFDA UDI	Class I	Active
Medis	ETT-X22-70	FDA UDI	Class II	Active
Medis	NF419	FDA UDI	Class I	Active
CareTouch	CTMK w/cs	FDA UDI	Class II	Active
Nasopharyngeal Airway	NF104	EUDAMEDFDA UDI	Class I	Active
Medisign Blood Glucose Monitoring System	K111456	FDA 510(k)	Class II	Active
Medisign MM1000 BT Blood Glucose Monitoring System, Medisign MM1100 BT Blood Glucose Monitoring System, Medisign MM1200 BT Blood Glucose Monitoring System, Smart Diabetes Bluetooth Blood Glucose Monitoring System, Medisign MM 1000 BT MULTI Blood Glucose Monitoring System, Medisign MM 1100 BT MULTI Blood Glucose Monitoring System, Medisign MM 1200 BT MULTI Blood Glucose Monitoring System, Smart Diabetes Bluetooth Pro Blood Glucose Monitoring System	K152534	FDA 510(k)	Class II	Active
Disposable Endotracheal tube, sterile, AccuCuff	K160694	FDA 510(k)	Class II	Active
Endotracheal Tube	K190274	FDA 510(k)	Class II	Active
Accucuff Cuff Pressure Indicator	K182548	EUDAMEDFDA 510(k)FDA UDI	Class II	Active
Medisign GH81 Blood Glucose Monitoring System, Medisign GH82 Blood Glucose Monitoring System, Medisign GH83 Blood Glucose Monitoring System, Medisign GH81 BT Blood Glucose Monitoring System, Medisign GH82 BT Blood Glucose Monitoring System, Medisign GH83 BT Blood Glucose Monitoring System	K162564	FDA 510(k)	Class II	Active
Medisign Blood Glucse Monitoring System, Medisign Multi Blood Glucose Monitoring System	K133260	FDA 510(k)	Class II	Active
Endotracheal Tubes	ETT-P10-20	EUDAMEDFDA UDI	Class IIa	Active
Bougie	000946	EUDAMED	Class I	Active
Nasopharyngeal Airway	NF106	EUDAMEDFDA UDI	Class I	Active
Double-lumen Endobronchial Tubes	DLT-R10-37	EUDAMED	Class IIa	Active

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