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
Bl700	BL700	EUDAMED	Class I	Active
Bone Management	LC00A 030	EUDAMEDFDA UDI	Class I	Active
Bone Management	SW0L1	EUDAMEDFDA UDI	Class I	Active
0jk02	0JK02	EUDAMED	Class I	Active
Oktagon	17372	EUDAMEDFDA UDI	Class I	Active
Bs540	BS540	EUDAMED	Class I	Active
Oktagon	64549	EUDAMEDFDA UDI	Class I	Active
Bone Management	IET02	EUDAMED	Class I	Active
Bhrc16	BHRC16	EUDAMED	Class I	Active
Oktagon	64550	EUDAMEDFDA UDI	Class I	Active
Or102 Gel	OR102 GEL	EUDAMED	Class I	Active
Bone Management	HI328	EUDAMEDFDA UDI	Class I	Active
Bone Management	CA0RA	EUDAMEDFDA UDI	Class I	Active
myplant	ZHR02	EUDAMEDFDA UDI	Class I	Active
Kabutsel 002	KABUTSEL 002	EUDAMED	Class I	Active
Bs151 Gel	BS151 GEL	EUDAMED	Class I	Active
myplant	ZSD1S	EUDAMEDFDA UDI	Class I	Active
Tr000	TR000	EUDAMED	Class I	Active
11100	11100	EUDAMED	Class I	Active
Bone Management	SL0	EUDAMEDFDA UDI	Class I	Active
Bs670	BS670	EUDAMED	Class I	Active
Cp300	CP300	EUDAMED	Class I	Active
Bone Management	BE001 045	EUDAMEDFDA UDI	Class I	Active
Bl302	BL302	EUDAMED	Class I	Active
myplant	ZRDI1	EUDAMEDFDA UDI	Class I	Active
Hgsd	HGSD	EUDAMED	Class I	Active
Bone Management	39MI041	EUDAMEDFDA UDI	Class I	Active
myplant	PUP01	EUDAMED	Class I	Active
Oktagon	22119	EUDAMEDFDA UDI	Class I	Active
Oktagon	93734	EUDAMEDFDA UDI	Class I	Active
myplant	ZAI01	EUDAMEDFDA UDI	Class I	Active
Bone Management	39MI042	EUDAMEDFDA UDI	Class I	Active
Bs151	BS151	EUDAMED	Class I	Active
Oktagon	64547	EUDAMEDFDA UDI	Class I	Active
Bone Management	CL039	EUDAMEDFDA UDI	Class I	Active
Bhnc16	BHNC16	EUDAMED	Class I	Active
Bone Management	MSTDM	EUDAMEDFDA UDI	Class I	Active
Or606	OR606	EUDAMED	Class I	Active
Bone Management	MI099	EUDAMEDFDA UDI	Class I	Active
Bone Management	IET04	EUDAMED	Class I	Active
Bone Management	TSBOX002	EUDAMED	Class I	Active
Bone Management	MI105	EUDAMEDFDA UDI	Class I	Active
Vi0ra0ra	VI0RA0RA	EUDAMED	Class I	Active
Bone Management	CL056	EUDAMEDFDA UDI	Class I	Active
Bone Management	39VCD85	EUDAMEDFDA UDI	Class I	Active
Bone Management	HN005 045	EUDAMEDFDA UDI	Class I	Active
Bs170	BS170	EUDAMED	Class I	Active
myplant	ZHR01	EUDAMEDFDA UDI	Class I	Active
Bone Management	CL059	EUDAMEDFDA UDI	Class I	Active
Oktagon	64566	EUDAMEDFDA UDI	Class I	Active

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