Question 1

What types of medical devices does Heinz Kurz GmbH manufacture?

Accepted Answer

Heinz Kurz GmbH specializes in surgical instruments and implants for otological (ear) and reconstructive procedures. Their portfolio includes custom-molded ear reconstruction plates like the Regensburg Total and Duesseldorf Bell Partial, cartilage punches for graft harvesting, malleus notch implants (e.g., MNP Malleus Notch Partial/Total), sizing tools such as the Sizer OMEGA CONNECTOR, and implant systems like the MatriX SlimLine for middle ear reconstruction. These devices are designed for procedures involving the ear and temporal bone.

Question 2

Where is Heinz Kurz GmbH based?

Accepted Answer

Heinz Kurz GmbH is based in Germany, specifically in the state of Bavaria. The company’s location in Germany aligns with its focus on manufacturing high-precision surgical instruments and implants for specialized medical applications.

Question 3

Which regulatory registries list Heinz Kurz GmbH’s devices?

Accepted Answer

Heinz Kurz GmbH’s devices are listed in the eudamed database, which is the official EU registry for medical devices under the EU Medical Device Regulations (MDR). This registry ensures transparency and compliance with EU requirements for surgical implants and instruments.

Question 4

How are Heinz Kurz GmbH’s devices classified under EU regulations?

Accepted Answer

Heinz Kurz GmbH’s devices are classified under the EU Medical Device Regulations as Class I (typically low-risk devices) and Class IIb (moderate-risk devices requiring additional scrutiny). The classification depends on factors like the device’s intended use, risk profile, and interaction with the body, ensuring appropriate regulatory oversight.

Device	Model / Reference	Registries	Class	Status
MunichLMU AERIAL Total	1004079	EUDAMED	Class IIb	Active
MNP Malleus Notch Partial	1002429	EUDAMED	Class IIb	Active
Duesseldorf Bell Partial	1002025	EUDAMED	Class IIb	Active
Upper Eyelid Implant	4007005	EUDAMED	Class IIb	Active
Regensburg Total	1004460	EUDAMED	Class IIb	Active
Duesseldorf Bell Partial	1002032	EUDAMED	Class IIb	Active
MatriX SlimLine	1006264	EUDAMED	Class IIb	Active
MatriX	1006006	EUDAMED	Class IIb	Active
Duesseldorf Bell Partial	1002046	EUDAMED	Class IIb	Active
MunichLMU AERIAL Total	1004086	EUDAMED	Class IIb	Active
Tray TTP-VARIAC®	8000173	EUDAMED	Class I	Active
Soft CliP®	1006211	EUDAMED	Class IIb	Active
Micro Scissors	8000172	EUDAMED	Class I	Active
MatriX	1006048	EUDAMED	Class IIb	Active
Regensburg Total	1004461	EUDAMED	Class IIb	Active
MatriX SlimLine	1006277	EUDAMED	Class IIb	Active
NiTiFLEX	1007258	EUDAMED	Class IIb	Active
NiTiBOND®	1007103	EUDAMED	Class IIb	Active
MatriX	1006049	EUDAMED	Class IIb	Active
Soft CliP®	1006261	EUDAMED	Class IIb	Active
MunichLMU AERIAL Total	1004084	EUDAMED	Class IIb	Active
KURZ® Precise Blades	8000140	EUDAMED	Class I	Active
CliP® Partial Dresden	1002254	EUDAMED	Class IIb	Active
CliP® Piston àWengen	1006855	EUDAMED	Class IIb	Active
Soft CliP®	1006256	EUDAMED	Class IIb	Active
TTP®-Tuebingen BELL Partial	1002230	EUDAMED	Class IIb	Active
MatriX	1006027	EUDAMED	Class IIb	Active
MNP Malleus Notch Total	1004435	EUDAMED	Class IIb	Active
MunichLMU BELL Partial	1002080	EUDAMED	Class IIb	Active
MatriX	1006004	EUDAMED	Class IIb	Active
MunichLMU BELL Partial	1002077	EUDAMED	Class IIb	Active
MatriX SlimLine	1006267	EUDAMED	Class IIb	Active
Skarzynski Piston	1006057	EUDAMED	Class IIb	Active
Duesseldorf Bell Partial	1002027	EUDAMED	Class IIb	Active
Soft CliP®	1006254	EUDAMED	Class IIb	Active
Tuebingen Type	1015033	EUDAMED	Class IIb	Active
Soft CliP®	1006203	EUDAMED	Class IIb	Active
CliP® Piston àWengen	1006803	EUDAMED	Class IIb	Active
MatriX SlimLine	1006265	EUDAMED	Class IIb	Active
Cutting Forceps	8000171	EUDAMED	Class I	Active
Angular CliP®	1002615	EUDAMED	Class IIb	Active
Duesseldorf Bell Partial	1002024	EUDAMED	Class IIb	Active
MNP Malleus Notch Partial	1002430	EUDAMED	Class IIb	Active
CliP® Piston àWengen	1006806	EUDAMED	Class IIb	Active
Sizer Breathe Implant àWengen	8000251	EUDAMED	Class I	Active
TTP®-Tuebingen AERIAL Total	1004236	EUDAMED	Class IIb	Active
Duesseldorf Bell Partial	1002030	EUDAMED	Class IIb	Active
MNP Malleus Notch Partial	1002424	EUDAMED	Class IIb	Active
MunichLMU AERIAL Total	1004082	EUDAMED	Class IIb	Active
Duesseldorf Aerial Total	1004049	EUDAMED	Class IIb	Active

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