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
RapidLink	810612100	EUDAMEDFDA UDI	Class I	Active
AccuBlade	800200600	FDA UDI	Class I	Active
EasyPass	801302500	EUDAMEDFDA UDI	Class I	Active
PragmaTool	801961700	FDA UDI	Class I	Active
DuraBurr	800300900	FDA UDI	Class I	Active
PragmaTool	RJ8112032	FDA UDI	Class I	Active
EasyPass	810500700	FDA UDI	Class I	Active
AccuBlade	800200900	FDA UDI	Class I	Active
PragmaTool	RJ8112031	FDA UDI	Class I	Active
PragmaTool	RJ8112029	FDA UDI	Class I	Active
PragmaTool	801961900	FDA UDI	Class I	Active
PragmaTool	RJ8112033	FDA UDI	Class I	Active
DuraBurr	800300800	FDA UDI	Class I	Active
RapidLink	810600200	FDA UDI	Class I	Active
EasyPass	810503400	EUDAMEDFDA UDI	Class I	Active
TracPort	810700200	FDA UDI	Class I	Active
RemoHip	801942900	EUDAMEDFDA UDI	Class I	Active
AccuBlade	800200400	EUDAMED	Class IIa	Active
AccuBlade	800200500	EUDAMEDFDA UDI	Class IIa	Active

Hangzhou Rejoin Mastin Medical Device Co., Ltd.

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