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
Regensburg Total	1004462	EUDAMED	Class IIb	Active
Angular Plester	1002612	EUDAMED	Class IIb	Active
Tray Cartilage Punch	8000176	EUDAMED	Class I	Active
Duesseldorf Bell Partial	1002047	EUDAMED	Class IIb	Active
Duesseldorf Aerial Total	1004046	EUDAMED	Class IIb	Active
MNP Malleus Notch Partial	1002425	EUDAMED	Class IIb	Active
MNP Malleus Notch Total	1004439	EUDAMED	Class IIb	Active
Sizer OMEGA CONNECTOR	8000555	EUDAMED	Class I	Active
MatriX SlimLine	1006286	EUDAMED	Class IIb	Active
MNP Malleus Notch Total	1004436	EUDAMED	Class IIb	Active
MatriX SlimLine	1006280	EUDAMED	Class IIb	Active
Duesseldorf Bell Partial	1002033	EUDAMED	Class IIb	Active
Breathe Implant àWengen	6002011	EUDAMED	Class IIb	Active
MNP Malleus Notch Partial	1002428	EUDAMED	Class IIb	Active
Tray Stainless Steel	8000124	EUDAMED	Class I	Active
Duesseldorf Aerial Total	1004043	EUDAMED	Class IIb	Active
Sizer Breathe Implant àWengen	8000252	EUDAMED	Class I	Active
MNP Malleus Notch Total	1004444	EUDAMED	Class IIb	Active
MNP Malleus Notch Total	1004437	EUDAMED	Class IIb	Active
Duesseldorf Aerial Total	1004034	EUDAMED	Class IIb	Active
Sizer Breathe Implant àWengen	8000253	EUDAMED	Class I	Active
MatriX	1006031	EUDAMED	Class IIb	Active
NiTiFLEX	1007204	EUDAMED	Class IIb	Active
TTP®-Tuebingen BELL Partial	1002223	EUDAMED	Class IIb	Active
Test Weight Set	8000111	EUDAMED	Class I	Active
Duesseldorf Aerial Total	1004044	EUDAMED	Class IIb	Active
Titanium Micro Closing Forceps	8000137	EUDAMED	Class I	Active
Tray KURZ® Precise	8000177	EUDAMED	Class I	Active
MatriX	1006046	EUDAMED	Class IIb	Active
K-Piston	1006111	EUDAMED	Class IIb	Active
TVT Trocar	1015075	EUDAMED	Class IIb	Active
Omega Connector	1004930	EUDAMED	Class IIb	Active
Cartilage Forceps Schimanski Design	8000193	EUDAMED	Class I	Active
NiTiFLEX	1007203	EUDAMED	Class IIb	Active
MatriX	1006050	EUDAMED	Class IIb	Active
Titanium Tweezers	8000136	EUDAMED	Class I	Active
MunichLMU AERIAL Total	1004076	EUDAMED	Class IIb	Active
MatriX	1006011	EUDAMED	Class IIb	Active
MunichLMU BELL Partial	1002074	EUDAMED	Class IIb	Active
CliP® Partial Dresden	1002256	EUDAMED	Class IIb	Active
CliP Piston àWengen	1006804	EUDAMED	Class IIb	Active
Cartilage Punch	8000200	EUDAMED	Class I	Active
NiTiBOND®	1007104	EUDAMED	Class IIb	Active
MatriX	1006023	EUDAMED	Class IIb	Active
Soft CliP®	1006209	EUDAMED	Class IIb	Active
MatriX	1006009	EUDAMED	Class IIb	Active
CliP® Piston àWengen	1006854	EUDAMED	Class IIb	Active
NiTiFLEX	1007207	EUDAMED	Class IIb	Active
CliP® Piston MVP	1006759	EUDAMED	Class IIb	Active
Skarzynski Piston	1006058	EUDAMED	Class IIb	Active

Heinz Kurz GmbH

What Heinz Kurz GmbH makes

Frequently asked questions

Information

Catalogue (207)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities

FDA Establishments (1)