Question 1

What types of medical devices does C.HAFNER GmbH + Co. KG manufacture?

Accepted Answer

C.HAFNER GmbH + Co. KG specializes in dental casting alloys and related materials used in dental restorations. Their portfolio includes gold-based alloys like Orplid H and Pangold LFC, ceramic-fused-to-metal frameworks such as Pangold Keramik N2, welding wires (e.g., Orplid GK and Orplid LFC), and activators for dental hardening processes (e.g., AGC Härte and AGC NEM series). These products are designed for both machined and cast dental components, primarily for crowns, bridges, and other restorative applications.

Question 2

Where is C.HAFNER GmbH + Co. KG based, and what does that mean for its regulatory compliance?

Accepted Answer

C.HAFNER GmbH + Co. KG is based in Germany, which places its devices under the jurisdiction of the European Union’s medical device regulations. Since the company manufactures dental casting alloys and related products, these fall under the EU’s medical device framework, ensuring compliance with EU-wide standards for safety, performance, and traceability. The fact that its devices are listed in the eudamed registry reflects this adherence to EU regulatory requirements.

Question 3

Which EU medical device registries list C.HAFNER’s products, and why is this important?

Accepted Answer

C.HAFNER’s dental casting alloys and related devices are listed in the eudamed registry, the official EU database for medical devices. This registry is critical because it provides transparency on device manufacturers, their products, and regulatory status within the EU. Listing in eudamed ensures that healthcare professionals, regulators, and authorities can verify the manufacturer’s identity and the classification of their devices, which is particularly important for Class IIa products like those offered by C.HAFNER.

Question 4

How are C.HAFNER’s dental casting alloys classified under EU medical device regulations?

Accepted Answer

C.HAFNER’s dental casting alloys and related products are classified as Class IIa medical devices under EU regulations. This classification is determined based on factors such as the intended use, potential risks, and the body’s interaction with the device. Class IIa devices are considered to have a moderate risk and require compliance with specific EU directives, including design controls, clinical evaluations, and post-market surveillance, to ensure their safety and performance in dental applications.

Device	Model / Reference	Registries	Class	Status
Orplid H, gefräst	1570	EUDAMED	Class IIa	Active
Pangold LFC, Schweißdraht 0, 35 mm	1597	EUDAMED	Class IIa	Active
Orplid GK, Schweißdraht 0, 35 mm	1223	EUDAMED	Class IIa	Active
AGC Härte Aktivator	8523	EUDAMED	Class IIa	Active
AGC NEM Aktivator	8524	EUDAMED	Class IIa	Active
AURUMED Eco 52	43537	EUDAMED	Class IIa	Active
Pangold Keramik N2, gefräst	1581	EUDAMED	Class IIa	Active
Orplid LFC, Guss	1489	EUDAMED	Class IIa	Active
Orplid Universal, Guss	1509	EUDAMED	Class IIa	Active
AURUMED Pal KF	49162	EUDAMED	Class IIa	Active
Orplid CF, Guss	1121	EUDAMED	Class IIa	Active
Elfenbeingold G2, Guss	1002	EUDAMED	Class IIa	Active
Orplid Keramik Lot CF 950	1291	EUDAMED	Class IIa	Active
Orplid Inlay, Schweißdraht 0, 35 mm	1277	EUDAMED	Class IIa	Active
CeHa LIGHT PLUS, Guss	1546	EUDAMED	Class IIa	Active
Orplid Keramik Lot 1050	1073	EUDAMED	Class IIa	Active
Orplid Keramik 2, Schweißdraht 0, 35 mm	1204	EUDAMED	Class IIa	Active
AURUMED Eco 26, Schweißdraht 0, 35 mm	45296	EUDAMED	Class IIa	Active
Orplid EH, Guss	1025	EUDAMED	Class IIa	Active
Elfenbeingold G2, Schweißdraht 0, 35 mm	1247	EUDAMED	Class IIa	Active
Biorplid G1, Guss	1579	EUDAMED	Class IIa	Active
Interpal, Guss	1201	EUDAMED	Class IIa	Active
AURUMED Auruloy Basis	43539	EUDAMED	Class IIa	Active
AURUMED Eco 26	45077	EUDAMED	Class IIa	Active
Unilight Classic, Guss	1527	EUDAMED	Class IIa	Active
Orplid Keramik 3, Schweißdraht 0, 35 mm	1229	EUDAMED	Class IIa	Active
Biorplid G2, Guss	1562	EUDAMED	Class IIa	Active
Orplid LFC, Schweißdraht 0, 35 mm	1502	EUDAMED	Class IIa	Active
Orplid Keramik 21, Schweißdraht 0, 35 mm	1534	EUDAMED	Class IIa	Active
Orplid Keramik Lot 1020	1075	EUDAMED	Class IIa	Active
AURUMED Bio GG	1604	EUDAMED	Class IIa	Active
Orplid TK, Guss	1574	EUDAMED	Class IIa	Active
Orplid PCF, Schweißdraht 0, 35 mm	1296	EUDAMED	Class IIa	Active
Orplid PF, Schweißdraht 0, 35 mm	1208	EUDAMED	Class IIa	Active
Orplid Keramik 4, Guss	1029	EUDAMED	Class IIa	Active
Interpal S, Guss	1565	EUDAMED	Class IIa	Active
Orplid Lot CF 860	1292	EUDAMED	Class IIa	Active
Pangold Keramik N, Guss	1052	EUDAMED	Class IIa	Active
Cehadentor Keramik Lot 1110	1074	EUDAMED	Class IIa	Active
Universal Lot 770	1067	EUDAMED	Class IIa	Active
AURUMED S-Plus	1603	EUDAMED	Class IIa	Active
Pangold, Guss	1048	EUDAMED	Class IIa	Active
Orplid Keramik Lot C 970	1419	EUDAMED	Class IIa	Active
Orplid Lot CF 720	1256	EUDAMED	Class IIa	Active
Orplid Keramik PF, Schweißdraht 0, 35 mm	1227	EUDAMED	Class IIa	Active
Orplid Lot 760	1070	EUDAMED	Class IIa	Active
Orplid Keramik Lot 1070	1557	EUDAMED	Class IIa	Active
Orplid Keramik 2, Guss	1031	EUDAMED	Class IIa	Active
CeHa MILL PLUS, gefräst	1602	EUDAMED	Class IIa	Active
Orplid Lot 735	1071	EUDAMED	Class IIa	Active

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