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	CL065	EUDAMEDFDA UDI	Class I	Active
231kh	231KH	EUDAMEDFDA UDI	Class I	Active
Or622	OR622	EUDAMED	Class I	Active
Bs670gel	BS670GEL	EUDAMED	Class I	Active
myplant	ZEIK1	EUDAMEDFDA UDI	Class I	Active
4500176722030	4500176722030	EUDAMEDFDA UDI	Class I	Active
4500176722035	4500176722035	EUDAMEDFDA UDI	Class I	Active
Bone Management	BHO 090	EUDAMEDFDA UDI	Class I	Active
Oktagon	22015	EUDAMEDFDA UDI	Class I	Active
Bone Management	CA00G	EUDAMEDFDA UDI	Class I	Active
Oktagon	64570	EUDAMEDFDA UDI	Class I	Active
Gr700 Gel	GR700 GEL	EUDAMED	Class I	Active
myplant	ZEI0M	EUDAMEDFDA UDI	Class I	Active
Bone Management	MP11	EUDAMEDFDA UDI	Class I	Active
Oktagon	64546	EUDAMEDFDA UDI	Class I	Active
Bone Management	MP33	EUDAMED	Class I	Active
Bone Management	39MI083	EUDAMEDFDA UDI	Class I	Active
Or630	OR630	EUDAMED	Class I	Active
Or603	OR603	EUDAMED	Class I	Active
Oktagon	64544	EUDAMEDFDA UDI	Class I	Active
Bone Management	MI156	EUDAMEDFDA UDI	Class I	Active
12100	12100	EUDAMED	Class I	Active
Gr102 Gel	GR102 GEL	EUDAMED	Class I	Active
Dbh03 055	DBH03 055	EUDAMED	Class I	Active
Bone Management	HN007 050	EUDAMEDFDA UDI	Class I	Active
Bone Management	CL054	EUDAMEDFDA UDI	Class I	Active
Bone Management	CL012	EUDAMEDFDA UDI	Class I	Active
Oktagon	31159	EUDAMEDFDA UDI	Class I	Active
Bs170	BS170	EUDAMED	Class I	Active
Oktagon	64558	EUDAMEDFDA UDI	Class I	Active
Oktagon	22075	EUDAMEDFDA UDI	Class I	Active
Bone Management	BMP17	EUDAMEDFDA UDI	Class I	Active
12300	12300	EUDAMED	Class I	Active
myplant	PUP02	EUDAMED	Class I	Active
0sc02	0SC02	EUDAMED	Class I	Active
Bs240	BS240	EUDAMED	Class I	Active
Bone Management	CL041	EUDAMEDFDA UDI	Class I	Active
Bone Management	CBKBV	EUDAMEDFDA UDI	Class I	Active
myplant	PAK02	EUDAMED	Class I	Active
Gs2	GS2	EUDAMED	Class I	Active
Oktagon	31165	EUDAMEDFDA UDI	Class I	Active
Bone Management	39MI204	EUDAMEDFDA UDI	Class I	Active
Oktagon	22096	EUDAMEDFDA UDI	Class I	Active
Bl702	BL702	EUDAMED	Class I	Active
Bone Management	CL011	EUDAMEDFDA UDI	Class I	Active
La	LA	EUDAMED	Class I	Active
myplant	ZSDXS	EUDAMEDFDA UDI	Class I	Active
Bone Management	CL051	EUDAMEDFDA UDI	Class I	Active
Bs540gel	BS540GEL	EUDAMED	Class I	Active
Bone Management	MI096	EUDAMEDFDA UDI	Class I	Active

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