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	HI070	EUDAMEDFDA UDI	Class I	Active
Bone Management	CL008	EUDAMEDFDA UDI	Class I	Active
Dbh06 038	DBH06 038	EUDAMED	Class I	Active
Bone Management	MP14	EUDAMEDFDA UDI	Class I	Active
4500176722020	4500176722020	EUDAMEDFDA UDI	Class I	Active
Or603 Gel	OR603 GEL	EUDAMED	Class I	Active
Bs470	BS470	EUDAMED	Class I	Active
Bone Management	HI329	EUDAMEDFDA UDI	Class I	Active
Bl603	BL603	EUDAMED	Class I	Active
Bone Management	MI159	EUDAMEDFDA UDI	Class I	Active
Bone Management	BKM00	EUDAMEDFDA UDI	Class I	Active
Or300	OR300	EUDAMED	Class I	Active
Gsnc	GSNC	EUDAMED	Class I	Active
Oktagon	38073	EUDAMEDFDA UDI	Class I	Active
Or300 Gel	OR300 GEL	EUDAMED	Class I	Active
Oktagon	31178	EUDAMEDFDA 510(k)	Class I	Active
Bone Management	SWRA1	EUDAMED	Class I	Active
Bone Management	BMR01	EUDAMEDFDA UDI	Class I	Active
Bs441gel	BS441GEL	EUDAMED	Class I	Active
Bone Management	CL053	EUDAMEDFDA UDI	Class I	Active
Oktagon	63978	EUDAMEDFDA UDI	Class I	Active
Oktagon	55487	EUDAMED	Class I	Active
Bl703	BL703	EUDAMED	Class I	Active
Oktagon	31166	EUDAMEDFDA UDI	Class I	Active
Bs141 Gel	BS141 GEL	EUDAMED	Class I	Active
0jk01	0JK01	EUDAMED	Class I	Active
2565	2565	EUDAMED	Class I	Active
Bone Management	MI131	EUDAMEDFDA UDI	Class I	Active
Bone Management	CA5RA	EUDAMEDFDA UDI	Class I	Active
Ra	RA	EUDAMED	Class I	Active
Bone Management	CARA3	EUDAMEDFDA UDI	Class I	Active
Bone Management	39VCD35	EUDAMEDFDA UDI	Class I	Active
Oktagon	22089	EUDAMEDFDA UDI	Class I	Active
Bone Management	39MI158	EUDAMEDFDA UDI	Class I	Active
0bc02	0BC02	EUDAMED	Class I	Active
Oktagon	77501	EUDAMED	Class I	Active
Jmpca	JMPCA	EUDAMED	Class I	Active
Mphgs	MPHGS	EUDAMED	Class I	Active
11300	11300	EUDAMED	Class I	Active
0rl01	0RL01	EUDAMEDFDA UDI	Class I	Active
Bone Management	ASTKH 025	EUDAMEDFDA UDI	Class I	Active
Oktagon	89048	EUDAMEDFDA UDI	Class I	Active
Bone Management	CAFCK	EUDAMEDFDA UDI	Class I	Active
Oktagon	90504	EUDAMED	Class I	Active
4500176722025	4500176722025	EUDAMEDFDA UDI	Class I	Active
Bone Management	CL021	EUDAMEDFDA UDI	Class I	Active
Bs740gel	BS740GEL	EUDAMED	Class I	Active
Bone Management	39MI205	EUDAMEDFDA UDI	Class I	Active
Sw703	SW703	EUDAMED	Class I	Active
Bone Management	CL064	EUDAMEDFDA UDI	Class I	Active

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