Question 1

What types of medical devices does Hager & Meisinger GmbH primarily manufacture?

Accepted Answer

Hager & Meisinger GmbH specializes in surgical instrument and implant racks, such as models 31410, 31310, and 31210. Their portfolio also includes bone management systems, which are used in dental and surgical procedures. These devices are designed to organize, store, and manage surgical tools and implants in clinical settings.

Question 2

Where is Hager & Meisinger GmbH based, and what does this imply about their regulatory environment?

Accepted Answer

Hager & Meisinger GmbH is based in Germany, which means their devices are subject to EU medical device regulations. Since their products are listed in the EU’s eudamed registry, they comply with the requirements for registration under EU Medical Device Regulation (MDR) or Medical Device Directive (MDD). This registry helps ensure transparency and traceability of devices within the European market.

Question 3

Which EU regulatory database lists devices manufactured by Hager & Meisinger GmbH?

Accepted Answer

Devices from Hager & Meisinger GmbH are listed in the eudamed registry, the official EU database for medical devices. This registry is maintained under EU medical device regulations and provides public access to information about manufacturers, devices, and their regulatory status within the European Union.

Question 4

How are the devices produced by Hager & Meisinger GmbH classified under EU regulations?

Accepted Answer

The devices manufactured by Hager & Meisinger GmbH fall into Class I and Class IIb categories under EU medical device regulations. Class I devices are generally considered low-risk, while Class IIb devices involve a higher level of risk and require additional conformity assessment procedures, such as clinical evaluations or designated examination bodies. The classification determines the regulatory requirements for market placement.

Device	Model / Reference	Registries	Class	Status
Bone Management	CAG0G	EUDAMEDFDA UDI	Class I	Active
Kabutsel 003	KABUTSEL 003	EUDAMED	Class I	Active
Bone Management	BHO 110	EUDAMEDFDA UDI	Class I	Active
Ex7	EX7	EUDAMED	Class I	Active
Oktagon	93721	EUDAMEDFDA UDI	Class I	Active
Bone Management	HN006 050	EUDAMEDFDA UDI	Class I	Active
Bone Management	36BMR02	EUDAMEDFDA UDI	Class I	Active
Oktagon	64567	EUDAMEDFDA UDI	Class I	Active
Bone Management	CL057	EUDAMEDFDA UDI	Class I	Active
Bscm0	BSCM0	EUDAMED	Class I	Active
Bone Management	HI326	EUDAMEDFDA UDI	Class I	Active
Or302 Gel	OR302 GEL	EUDAMED	Class I	Active
Bone Management	MI154	EUDAMEDFDA UDI	Class I	Active
Oktagon	22074	EUDAMEDFDA UDI	Class I	Active
Bone Management	CL050	EUDAMEDFDA UDI	Class I	Active
Bone Management	ASTKH 033	EUDAMEDFDA UDI	Class I	Active
Gs1	GS1	EUDAMED	Class I	Active
myplant	ZAPS1	EUDAMEDFDA UDI	Class I	Active
Bl700 Gel	BL700 GEL	EUDAMED	Class I	Active
Bs171	BS171	EUDAMED	Class I	Active
Bone Management	CL017	EUDAMEDFDA UDI	Class I	Active
Bs470gel	BS470GEL	EUDAMED	Class I	Active
822565m	822565M	EUDAMED	Class I	Active
Bone Management	MP15	EUDAMEDFDA UDI	Class I	Active
Oktagon	57043	EUDAMED	Class I	Active
Oktagon	64556	EUDAMEDFDA UDI	Class I	Active
Bs441	BS441	EUDAMED	Class I	Active
Gs3	GS3	EUDAMED	Class I	Active
Bone Management	MI132	EUDAMEDFDA UDI	Class I	Active
Bone Management	CL034	EUDAMEDFDA UDI	Class I	Active
Bone Management	VC1PS	EUDAMEDFDA UDI	Class I	Active
Bone Management	GDH 023	EUDAMEDFDA UDI	Class I	Active
Pzn14	PZN14	EUDAMEDFDA UDI	Class I	Active
231kh	231KH	EUDAMEDFDA UDI	Class I	Active
231kh	231KH	EUDAMEDFDA UDI	Class I	Active
Cp400	CP400	EUDAMED	Class I	Active
Bone Management	CL052	EUDAMEDFDA UDI	Class I	Active
Or606 Gel	OR606 GEL	EUDAMED	Class I	Active
Bl300 Gel	BL300 GEL	EUDAMED	Class I	Active
Bs770gel	BS770GEL	EUDAMED	Class I	Active
Bone Management	GS6KT	EUDAMED	Class I	Active
Tr0000p	TR0000P	EUDAMED	Class I	Active
Bone Management	39MI139	EUDAMEDFDA UDI	Class I	Active
Oktagon	22117	EUDAMEDFDA UDI	Class I	Active
Oktagon	64542	EUDAMEDFDA UDI	Class I	Active
Bone Management	CL038	EUDAMEDFDA UDI	Class I	Active
Oktagon	31162	EUDAMEDFDA UDI	Class I	Active
Bone Management	HRKH1	EUDAMEDFDA UDI	Class I	Active
Bone Management	ASNKH 008	EUDAMEDFDA UDI	Class I	Active
Bone Management	MI098	EUDAMEDFDA UDI	Class I	Active

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