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	1004083	EUDAMED	Class IIb	Active
MNP Malleus Notch Total	1004438	EUDAMED	Class IIb	Active
Angular Piston	1006650	EUDAMED	Class IIb	Active
Angular Piston	1006652	EUDAMED	Class IIb	Active
Upper Eyelid Implant	4007002	EUDAMED	Class IIb	Active
K-Piston	1006160	EUDAMED	Class IIb	Active
Soft-CliP® Hook	8000127	EUDAMED	Class I	Active
MunichLMU AERIAL Total	1004078	EUDAMED	Class IIb	Active
TTP®-Tuebingen AERIAL Total	1004237	EUDAMED	Class IIb	Active
Angular Piston	1006600	EUDAMED	Class IIb	Active
NiTiBOND®	1007159	EUDAMED	Class IIb	Active
CliP® Partial Dresden	1002255	EUDAMED	Class IIb	Active
KURZ® Precise Cartilage Knife Set	8000155	EUDAMED	Class I	Active
TTP®-Tuebingen BELL Partial	1002224	EUDAMED	Class IIb	Active
Tuebingen Type	1015036	EUDAMED	Class IIb	Active
Breathe Implant àWengen	6002012	EUDAMED	Class IIb	Active
K-Piston	1006118	EUDAMED	Class IIb	Active
Duesseldorf Aerial Total	1004042	EUDAMED	Class IIb	Active
MNP Malleus Notch Total	1004442	EUDAMED	Class IIb	Active
Upper Eyelid Implant	4007008	EUDAMED	Class IIb	Active
NiTiBOND®	1007161	EUDAMED	Class IIb	Active
Upper Eyelid Implant	4007007	EUDAMED	Class IIb	Active
NiTiFLEX	1007206	EUDAMED	Class IIb	Active
MNP Malleus Notch Partial	1002426	EUDAMED	Class IIb	Active
NiTiBOND®	1007108	EUDAMED	Class IIb	Active
MatriX Offset	1006034	EUDAMED	Class IIb	Active
Duesseldorf Bell Partial	1002026	EUDAMED	Class IIb	Active
CliP® Piston àWengen	1006811	EUDAMED	Class IIb	Active
TTP®-Tuebingen BELL Partial	1002229	EUDAMED	Class IIb	Active
TTP®-Tuebingen AERIAL Total	1004240	EUDAMED	Class IIb	Active
K-Piston	1006158	EUDAMED	Class IIb	Active
TTP®-Tuebingen AERIAL Total	1004242	EUDAMED	Class IIb	Active
MunichLMU AERIAL Total	1004081	EUDAMED	Class IIb	Active
TTP®-Tuebingen AERIAL Total	1004239	EUDAMED	Class IIb	Active
Tray KURZ® Meter	8000174	EUDAMED	Class I	Active
MatriX Offset	1006036	EUDAMED	Class IIb	Active
MunichLMU AERIAL Total	1004077	EUDAMED	Class IIb	Active
SteadyCrimP Forceps	8000188	EUDAMED	Class I	Active
CliP® Piston àWengen	1006856	EUDAMED	Class IIb	Active
K-Piston	1006168	EUDAMED	Class IIb	Active
Skarzynski Piston	1006061	EUDAMED	Class IIb	Active
Trocar Handle	8000143	EUDAMED	Class I	Active
TTP®-Tuebingen BELL Partial	1002225	EUDAMED	Class IIb	Active
MunichLMU AERIAL Total	1004079	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
Duesseldorf Bell Partial	1002046	EUDAMED	Class IIb	Active
MunichLMU AERIAL Total	1004086	EUDAMED	Class IIb	Active

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