Question 1

What types of medical devices does Beijing Ruicheng Medical Supplies Co., Ltd. primarily manufacture?

Accepted Answer

Beijing Ruicheng Medical Supplies Co., Ltd. specializes in single-use blood lancets and safety lancets, such as the M6 Safety Lancet and E1 Safety Lancet, which are designed for blood glucose monitoring. The company also produces lancing devices like the RightLance Blood Lancing System for automated blood sampling. Additionally, it manufactures surgical utensil washers and disinfectors, including models like BeneCheck and AutoCheck, which are used for sterilizing medical instruments.

Question 2

Where is Beijing Ruicheng Medical Supplies Co., Ltd. based?

Accepted Answer

The company is headquartered in China, as indicated in its regulatory and product documentation.

Question 3

Which regulatory registries list devices manufactured by Beijing Ruicheng Medical Supplies Co., Ltd.?

Accepted Answer

Some of the company’s devices are listed in the EUDAMED database under the EU Medical Device Regulations, and others appear in the FDA’s 510(k) premarket notification registry. These registries track devices classified under EU Class I or Class II/IIa, depending on their risk level and intended use.

Question 4

How are devices from Beijing Ruicheng Medical Supplies Co., Ltd. classified under EU regulations?

Accepted Answer

The company’s devices are classified under the EU Medical Device Regulations as either Class I (low-risk devices like some single-use lancets) or Class II/IIa (moderate-risk devices, such as lancing systems or disinfectors). Classification depends on factors like the device’s purpose, duration of use, and potential health risks, ensuring appropriate regulatory oversight.

Device	Model / Reference	Registries	Class	Status
Family Dr.	RC-AD-VIU	EUDAMED	Class I	Active
M6 Safety Lancet	069504232M6BS	EUDAMED	Class IIa	Active
Lancing device	069504232LD13M2	EUDAMED	Class I	Active
M4 Safety needle	069504232M4BN	EUDAMED	Class IIa	Active
E1 Safety lancet	069504232E1AQ	EUDAMED	Class IIa	Active
RightLance Blood Lancing System	K222034	FDA 510(k)	Class II	Active
Disposable Safety Lancet	K222408	FDA 510(k)	Class II	Active
Ld17	069504232LD17MA	EUDAMED	Class I	Active
safety needle	069504232M3PlusTA	EUDAMED	Class IIa	Active
BeneCheck	I	EUDAMED	Class IIa	Active
BeneCheck	RC-AD-VIU	EUDAMED	Class I	Active
AutoCheck	I	EUDAMED	Class IIa	Active
M7 Safety Lancet	069504232M7BU	EUDAMED	Class IIa	Active
Lancing device	069504232LD19ME	EUDAMED	Class I	Active
Ld09	069504232LD09MB	EUDAMED	Class I	Active
Ld02	069504232LD02LV	EUDAMED	Class I	Active
Lancet	i	EUDAMED	Class IIa	Active
Novama	I	EUDAMED	Class IIa	Active
Microlife	RC-AD-VIU	EUDAMED	Class I	Active
Safety Lancet	V	EUDAMED	Class IIa	Active
Safety needle	069504232M3BL	EUDAMED	Class IIa	Active
Family Dr.	I	EUDAMED	Class IIa	Active
SANcheck	I	EUDAMED	Class IIa	Active
W2 Safety lancet	069504232W2CG	EUDAMED	Class IIa	Active
Alcohol Prep Pads	Z12011301	EUDAMED	Class I	Active
M5 Safety Lancet	069504232M5MiniRK	EUDAMED	Class IIa	Active
Procaps	I	EUDAMED	Class IIa	Active
Ld01	069504232LD01LT	EUDAMED	Class I	Active
Pempa	I	EUDAMED	Class IIa	Active
AutoCheck	RC-AD-VIU	EUDAMED	Class I	Active
Lancing device	069504232LD21LZ	EUDAMED	Class I	Active
Lancing device	069504232LD07M7	EUDAMED	Class I	Active
SANcheck	RC-AD-VIU	EUDAMED	Class I	Active

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