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	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
Or700 Gel	OR700 GEL	EUDAMED	Class I	Active
Bs340	BS340	EUDAMED	Class I	Active
Bone Management	SP30	EUDAMED	Class I	Active
Oktagon	55288	EUDAMED	Class I	Active
Sl1	SL1	EUDAMEDFDA UDI	Class I	Active
Bone Management	CAGKG	EUDAMEDFDA UDI	Class I	Active
Bone Management	HN009 060	EUDAMEDFDA UDI	Class I	Active
myplant	ZRA03	EUDAMEDFDA UDI	Class I	Active
Tlgs3	TLGS3	EUDAMED	Class I	Active
Bone Management	39MI089	EUDAMEDFDA UDI	Class I	Active
Bone Management	CL015	EUDAMEDFDA UDI	Class I	Active
Gs	GS	EUDAMED	Class I	Active
myplant	ZHT0M	EUDAMEDFDA UDI	Class I	Active
Bs270	BS270	EUDAMED	Class I	Active
Or102	OR102	EUDAMED	Class I	Active
Bone Management	CL063	EUDAMEDFDA UDI	Class I	Active
myplant	ZSDMU	EUDAMEDFDA UDI	Class I	Active
Bs541	BS541	EUDAMED	Class I	Active
Bone Management	ASTKH 021	EUDAMEDFDA UDI	Class I	Active
Bone Management	CA4RA	EUDAMEDFDA UDI	Class I	Active
Bs541gel	BS541GEL	EUDAMED	Class I	Active
Or100	OR100	EUDAMED	Class I	Active
Bone Management	39MI203	EUDAMEDFDA UDI	Class I	Active
11400	11400	EUDAMED	Class I	Active
Hgs	HGS	EUDAMED	Class I	Active
Gswp	GSWP	EUDAMED	Class I	Active
Bone Management	MI160	EUDAMEDFDA UDI	Class I	Active
Bone Management	SW150	EUDAMEDFDA UDI	Class I	Active
Bone Management	36VCD05	EUDAMEDFDA UDI	Class I	Active
Dbh03 057	DBH03 057	EUDAMED	Class I	Active
Oktagon	31167	EUDAMEDFDA UDI	Class I	Active
Bone Management	CL036	EUDAMEDFDA UDI	Class I	Active
Bone Management	HI007	EUDAMEDFDA UDI	Class I	Active
Bone Management	SW0K2	EUDAMEDFDA UDI	Class I	Active
myplant	ZDMA1	EUDAMEDFDA UDI	Class I	Active
Hg	HG	EUDAMED	Class I	Active
11200	11200	EUDAMED	Class I	Active
Bone Management	CR00G	EUDAMEDFDA UDI	Class I	Active
Oktagon	22034	EUDAMEDFDA UDI	Class I	Active
Hp33	HP33	EUDAMED	Class I	Active
Oktagon	31156	EUDAMEDFDA UDI	Class I	Active
Bone Management	39MI107	EUDAMEDFDA UDI	Class I	Active
Bs370	BS370	EUDAMED	Class I	Active
Oktagon	64553	EUDAMEDFDA UDI	Class I	Active
Bone Management	39VCD50	EUDAMEDFDA UDI	Class I	Active

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