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
AC Sizer System Partial	8000540	EUDAMED	Class I	Active
K-Piston	1006106	EUDAMED	Class IIb	Active
CliP® Partial Dresden	1002274	EUDAMED	Class IIb	Active
TTP®-Tuebingen BELL Partial	1002226	EUDAMED	Class IIb	Active
Skarzynski Piston	1006071	EUDAMED	Class IIb	Active
K-Piston	1006120	EUDAMED	Class IIb	Active
MatriX	1006024	EUDAMED	Class IIb	Active
CliP Partial FlexiBAL®	1002350	EUDAMED	Class IIb	Active
CliP® Piston MVP	1006762	EUDAMED	Class IIb	Active
CliP® Piston MVP	1006758	EUDAMED	Class IIb	Active
Upper Eyelid Implant	4007003	EUDAMED	Class IIb	Active
Skarzynski Piston	1006075	EUDAMED	Class IIb	Active
Angular Piston	1006651	EUDAMED	Class IIb	Active
Regensburg Total	1004459	EUDAMED	Class IIb	Active
MunichLMU BELL Partial	1002075	EUDAMED	Class IIb	Active
NiTiFLEX	1007208	EUDAMED	Class IIb	Active
KURZ® Meter	8000106	EUDAMED	Class I	Active
TTP-VARIAC® System Total	1004020	EUDAMED	Class IIb	Active
MatriX Offset	1006032	EUDAMED	Class IIb	Active
MatriX	1006007	EUDAMED	Class IIb	Active
TTP-VARIAC® System Partial	1002020	EUDAMED	Class IIb	Active
Duesseldorf Aerial Total	1004041	EUDAMED	Class IIb	Active
NiTiFLEX	1007259	EUDAMED	Class IIb	Active
AC Sizer System Total	8000550	EUDAMED	Class I	Active
Soft CliP®	1006204	EUDAMED	Class IIb	Active
Skarzynski Piston	1006063	EUDAMED	Class IIb	Active
Soft CliP®	1006207	EUDAMED	Class IIb	Active
K-Piston	1006110	EUDAMED	Class IIb	Active
Soft CliP®	1006255	EUDAMED	Class IIb	Active
NiTiFLEX	1007205	EUDAMED	Class IIb	Active
MatriX SlimLine	1006266	EUDAMED	Class IIb	Active
CliP® Piston MVP	1006760	EUDAMED	Class IIb	Active
MatriX	1006003	EUDAMED	Class IIb	Active
NiTiFLEX	1007211	EUDAMED	Class IIb	Active
NiTiBOND®	1007107	EUDAMED	Class IIb	Active
CliP® Partial Dresden	1002272	EUDAMED	Class IIb	Active
MNP Malleus Notch Total	1004434	EUDAMED	Class IIb	Active
MatriX	1006028	EUDAMED	Class IIb	Active
MatriX SlimLine	1006288	EUDAMED	Class IIb	Active
Tuebingen Type	1015031	EUDAMED	Class IIb	Active
Angular CliP®	1002617	EUDAMED	Class IIb	Active
MatriX SlimLine	1006268	EUDAMED	Class IIb	Active
Skarzynski Piston	1006077	EUDAMED	Class IIb	Active
Regensburg Total	1004458	EUDAMED	Class IIb	Active
Tuebingen Type	1015032	EUDAMED	Class IIb	Active
Upper Eyelid Implant	4007009	EUDAMEDFDA 510(k)	Class IIb	Active
MatriX SlimLine	1006278	EUDAMED	Class IIb	Active
Upper Eyelid Implant	4007006	EUDAMED	Class IIb	Active
MatriX SlimLine	1006273	EUDAMED	Class IIb	Active
CliP Partial FlexiBAL®	1002364	EUDAMED	Class IIb	Active

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