Question 1

What types of medical devices does Hangzhou Rejoin Mastin Medical Device Co., Ltd. manufacture?

Accepted Answer

Hangzhou Rejoin Mastin Medical Device Co., Ltd. specializes in reusable surgical instruments for general operating room use. Their portfolio includes drills, specialized tools like the ETButton and SmartArm, and a range of reusable surgical instruments designed for repeated use in surgical procedures across various medical specialties. These devices are engineered to meet sterile processing standards while ensuring durability and reliability.

Question 2

Where is Hangzhou Rejoin Mastin Medical Device Co., Ltd. based?

Accepted Answer

The company is based in China. While its headquarters and manufacturing operations are located there, its devices are also registered and distributed in compliance with international regulatory standards, including those applicable in the European market.

Question 3

Which regulatory registries list devices manufactured by Hangzhou Rejoin Mastin Medical Device Co., Ltd.?

Accepted Answer

Relevant devices from Hangzhou Rejoin Mastin Medical Device Co., Ltd. are registered in the EUDAMED database. This registry is used to track medical devices placed on the European market, ensuring transparency and compliance with EU regulations. The inclusion in EUDAMED reflects the company’s adherence to regulatory requirements for devices classified under EU classifications.

Question 4

How are the devices manufactured by Hangzhou Rejoin Mastin Medical Device Co., Ltd. classified under EU regulations?

Accepted Answer

The company’s devices are classified under EU regulations as Class I, Class IIa, and Class IIb. The classification depends on factors like the device’s intended use, risk level, and interaction with the body. For example, reusable surgical instruments like drills or specialized tools may fall into higher-risk classifications (e.g., Class IIa or IIb) due to their critical role in surgical procedures, while simpler instruments might qualify as Class I. These classifications determine the regulatory scrutiny and conformity assessment procedures required.

Device	Model / Reference	Registries	Class	Status
Reusable Surgical Instruments	RJ8124170	EUDAMED	Class I	Active
Reusable Surgical Instruments	RJ8102002	EUDAMED	Class I	Active
Reusable Surgical Instruments	RJ8125104	EUDAMED	Class I	Active
Reusable Surgical Instruments	RJ8100480	EUDAMED	Class I	Active
Reusable Surgical Instruments	RJ8124190	EUDAMED	Class I	Active
Reusable Surgical Instruments	801302100	EUDAMED	Class I	Active
Reusable Surgical Instruments	801915100	EUDAMED	Class I	Active
Reusable Surgical Instruments	801941600	EUDAMED	Class I	Active
Reusable Surgical Instruments	801302000	EUDAMED	Class I	Active
Reusable Surgical Instruments	810805100	EUDAMED	Class I	Active
Reusable Surgical Instruments	810805800	EUDAMED	Class I	Active
Reusable Surgical Instruments	RJ8124096	EUDAMED	Class I	Active
Reusable Surgical Instruments	801900800	EUDAMED	Class I	Active
SmartArm	RJ8147011	EUDAMED	Class I	Active
Reusable Surgical Instruments	801903800	EUDAMED	Class I	Active
Reusable Surgical Instruments	RJ8138011	EUDAMED	Class I	Active
Reusable Surgical Instruments	RJ8124172	EUDAMED	Class I	Active
Reusable Surgical Instruments	RJ8138002	EUDAMED	Class I	Active
Reusable Surgical Instruments	RJ8138004	EUDAMED	Class I	Active
Reusable Surgical Instruments	RJ8107052	EUDAMED	Class I	Active
Reusable Surgical Instruments	801310100	EUDAMED	Class I	Active
SmartArm	RJ8147006	EUDAMED	Class I	Active
PragmaTool	801961600	FDA UDI	Class I	Active
RemoHip	801945900	EUDAMEDFDA UDI	Class I	Active
RemoHip	801943300	EUDAMEDFDA UDI	Class I	Active
RemoHip	801947000	FDA UDI	Class I	Active
RemoHip	801947400	EUDAMEDFDA UDI	Class I	Active
Blades	800200800	FDA UDI	Class I	Active
PragmaTool	RJ8112034	FDA UDI	Class I	Active
RemoHip	801943500	EUDAMEDFDA UDI	Class I	Active
EasyPass	801904000	EUDAMEDFDA UDI	Class I	Active
EasyPass	810501700	FDA UDI	Class I	Active
RemoHip	801980700	EUDAMEDFDA UDI	Class I	Active
RemoHip	801943200	EUDAMEDFDA UDI	Class I	Active
EasyPass	810503500	FDA UDI	Class I	Active
EasyPass	801303100	EUDAMEDFDA UDI	Class I	Active
RemoHip	801940900	EUDAMEDFDA UDI	Class I	Active
PragmaTool	801962000	FDA UDI	Class I	Active
TracPort	810700900	FDA UDI	Class I	Active
RemoHip	801944000	EUDAMEDFDA UDI	Class I	Active
RemoHip	801941700	EUDAMEDFDA UDI	Class I	Active
PragmaTool	801961800	FDA UDI	Class I	Active
TracPort	810710400	FDA UDI	Class I	Active
AccuBlade	800200100	FDA UDI	Class I	Active
EasyPass	810500100	FDA UDI	Class I	Active
RemoHip	801943800	EUDAMEDFDA UDI	Class I	Active
RemoHip	801942500	EUDAMEDFDA UDI	Class I	Active
DuraBurr	800300100	FDA UDI	Class I	Active
PragmaTool	801961500	FDA UDI	Class I	Active
EasyPass	810500200	FDA UDI	Class I	Active

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