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	39VCD50	EUDAMEDFDA UDI	Class I	Active
Bone Management	CL055	EUDAMEDFDA UDI	Class I	Active
Bs440	BS440	EUDAMED	Class I	Active
Oktagon	31184	EUDAMED	Class I	Active
Bs770	BS770	EUDAMED	Class I	Active
64561dp0000	64561DP0000	EUDAMED	Class I	Active
Gr300 Gel	GR300 GEL	EUDAMED	Class I	Active
Bone Management	HN003 040	EUDAMEDFDA UDI	Class I	Active
Gs4	GS4	EUDAMED	Class I	Active
Lus66	LUS66	EUDAMED	Class I	Active
Bone Management	CA1RB	EUDAMEDFDA UDI	Class I	Active
Bone Management	BHO 070	EUDAMEDFDA UDI	Class I	Active
Gr700	GR700	EUDAMED	Class I	Active
Bhrp16	BHRP16	EUDAMED	Class I	Active
Bone Management	MSSDM	EUDAMEDFDA UDI	Class I	Active
Or402gel	OR402GEL	EUDAMED	Class I	Active
Cp002	CP002	EUDAMED	Class I	Active
Oktagon	64545	EUDAMEDFDA UDI	Class I	Active
Bone Management	PTH16	EUDAMEDFDA UDI	Class I	Active
Or630 Gel	OR630 GEL	EUDAMED	Class I	Active
Bone Management	39MI048	EUDAMEDFDA UDI	Class I	Active
Oktagon	64551	EUDAMEDFDA UDI	Class I	Active
Bone Management	CA0RB	EUDAMEDFDA UDI	Class I	Active
Bone Management	CL035	EUDAMEDFDA UDI	Class I	Active
Bone Management	39MI067	EUDAMEDFDA UDI	Class I	Active
Bone Management	UDWS1	EUDAMEDFDA UDI	Class I	Active
Oktagon	64568	EUDAMEDFDA UDI	Class I	Active
Bl702 Gel	BL702 GEL	EUDAMED	Class I	Active
Bone Management	HI327	EUDAMEDFDA UDI	Class I	Active
Oktagon	82689	EUDAMEDFDA UDI	Class I	Active
Bhrc12	BHRC12	EUDAMED	Class I	Active
Bone Management	CL058	EUDAMEDFDA UDI	Class I	Active
Bone Management	MSGSD	EUDAMEDFDA UDI	Class I	Active
Bs240gel	BS240GEL	EUDAMED	Class I	Active
Bone Management	TL0T1	EUDAMEDFDA UDI	Class I	Active
Oktagon	31015	EUDAMEDFDA UDI	Class I	Active
Hr	HR	EUDAMED	Class I	Active
myplant	PSB11	EUDAMED	Class I	Active
Bone Management	CARA4	EUDAMEDFDA UDI	Class I	Active
Oktagon	31163	EUDAMEDFDA UDI	Class I	Active
Bone Management	BE001 055	EUDAMEDFDA UDI	Class I	Active
Bone Management	CL009	EUDAMEDFDA UDI	Class I	Active
Bs440gel	BS440GEL	EUDAMED	Class I	Active
Bs270gel	BS270GEL	EUDAMED	Class I	Active
Gr202 Gel	GR202 GEL	EUDAMED	Class I	Active
Bone Management	BSS55	EUDAMED	Class I	Active
Hns04	HNS04	EUDAMEDFDA UDI	Class I	Active
Bone Management	CL061	EUDAMEDFDA UDI	Class I	Active
Oktagon	64569	EUDAMEDFDA UDI	Class I	Active
myplant	PAK01	EUDAMEDFDA UDI	Class I	Active

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