Question 1

What types of medical devices does Erbe Elektromedizin GmbH manufacture?

Accepted Answer

Erbe Elektromedizin GmbH specializes in electrosurgical devices, primarily electrodes and bipolar forceps. Their product range includes needle electrodes (standard and tungsten variants), spherical electrodes, loop electrodes, and specialized cutting tools like the HYBRIDknife® flex T-Type. These devices are designed for precision tasks in surgery, such as tissue dissection, coagulation, and ablation, and are used in various medical procedures.

Question 2

Where is Erbe Elektromedizin GmbH based?

Accepted Answer

Erbe Elektromedizin GmbH is headquartered in Germany. The company’s location in Germany aligns with its focus on developing high-precision medical devices for global use, particularly within the European market.

Question 3

Which regulatory registries list Erbe Elektromedizin GmbH’s devices?

Accepted Answer

Erbe Elektromedizin GmbH’s devices are registered in the eudamed database, which is the official EU registry for medical devices. This ensures transparency and compliance with European Union medical device regulations, allowing healthcare professionals and authorities to verify the manufacturer’s products.

Question 4

How are Erbe Elektromedizin GmbH’s devices classified under EU regulations?

Accepted Answer

Erbe Elektromedizin GmbH’s devices fall under Class I, Class IIa, and Class IIb classifications in the EU. These classifications determine the level of risk and regulatory scrutiny required. For example, electrodes like needle or spherical types may be classified as Class I (low risk), while more complex or invasive tools like the HYBRIDknife® flex T-Type could fall under Class IIa or IIb due to their specialized functions and potential risks.

Device	Model / Reference	Registries	Class	Status
Bipolar Kabel	20196-063	EUDAMED	Class I	Active
BiClamp® 150 C	20195-221	EUDAMED	Class IIb	Active
Schlingenelektr. Wolfr.; ø10mm	21191-142	EUDAMED	Class IIb	Active
Griffstück BiClamp® LAP	20195-145	EUDAMED	Class I	Active
Bipolare Pinzette; abgewinkelt	20195-493	EUDAMED	Class IIb	Active
FiAPC®-Sonde 2200 A	20132-222	EUDAMED	Class IIb	Active
Spatelelektrode; 2x18mm	21191-004	EUDAMED	Class IIb	Active
Spatelelektrode; 2, 3x19mm	21191-055	EUDAMED	Class IIb	Active
Slim-Line Elektrodengriff	20190-105	EUDAMED	Class IIb	Active
Spatelelektrode; 2x6mm	21191-107	EUDAMED	Class IIb	Active
Kugelelektrode; ø 4mm	21191-027	EUDAMED	Class IIb	Active
Bipolar Kabel	20196-045	EUDAMED	Class I	Active
LAP BiSect Micro	20195-204	EUDAMED	Class IIb	Active
Schlingenelek. Wolfr.; ø30mm	21191-050	EUDAMED	Class IIb	Active
Zweipedal-Fußschalter VIO®	20189-303	EUDAMED	Class IIb	Active
Bipolare Pinzette Premium	20195-508	EUDAMED	Class IIb	Active
Nadelelektrode; ø 0, 8x22mm	21191-168	EUDAMED	Class IIb	Active
Bandschlingenelektrode; ø 16mm	21191-039	EUDAMED	Class IIb	Active
Monopolar Kabel / Storz	20192-101	EUDAMED	Class I	Active
Spatelelektrode; 2, 3x19mm	21191-154	EUDAMED	Class IIb	Active
LAP Griffstück	20195-140	EUDAMED	Class I	Active
Neutralelektroden Kabel	20194-070	EUDAMED	Class I	Active
Nadelelektrode; ø 0, 8x17mm	21191-171	EUDAMED	Class IIb	Active
Monopolar Kabel	20192-110	EUDAMED	Class I	Active
Spatelelektrode; 2, 3x19mm	21191-061	EUDAMED	Class IIb	Active
Bipolar Kabel	20196-124	EUDAMED	Class I	Active
Bipolare Pinzette Premium	20195-560	EUDAMED	Class IIb	Active
Schlingenelektr. Wolfr.; 5x5mm	21191-167	EUDAMED	Class IIb	Active
Bipolare Pinzette; bajonett	20195-042	EUDAMED	Class IIb	Active
ERGO-Griffstück	20195-240	EUDAMED	Class I	Active
Absaugtrichter Anschluß	20321-010	EUDAMED	Class I	Active
Nadelelektrode Wolfr.; 0, 5x3mm	21191-119	EUDAMED	Class IIb	Active
Bipolare Pinzette Premium	20195-545	EUDAMED	Class IIb	Active
Kugelelektrode; ø 10mm	21191-033	EUDAMED	Class IIb	Active
Messerelektrode; 3, 4x24mm	21191-100	EUDAMED	Class IIb	Active
Schlingenelektr. Wolfr.; ø15mm	21191-043	EUDAMED	Class IIb	Active
Slim-Line Elektrodengriff	20190-104	EUDAMED	Class IIb	Active
Bipolare Pinzette; gerade	20195-499	EUDAMED	Class IIb	Active
Einmal-Elektrodengriff	20190-117	EUDAMED	Class IIb	Active
Bipolar Kabel	20196-048	EUDAMED	Class I	Active
Einsatz für BiClamp® 110	20195-232	EUDAMED	Class IIb	Active
Bipolare Pinzette Premium	20195-507	EUDAMED	Class IIb	Active
Slim-Line Elektrodengriff E 4	20190-090	EUDAMED	Class IIb	Active
Spatelelektrode; 3x24mm	21191-003	EUDAMED	Class IIb	Active
Zweipedal-Fußsch. ERBEJET® 2	20150-100	EUDAMED	Class IIb	Active
Nadelelektrode; ø 0, 8x15mm	21191-020	EUDAMED	Class IIb	Active
FiAPC®-Sonde 2200 A	20132-221	EUDAMED	Class IIb	Active
Bipolare Pinzette; abgewinkelt	20195-014	EUDAMED	Class IIb	Active
Bipolare Pinzette; bajonett	20195-491	EUDAMED	Class IIb	Active
Drahtschlingenelektrode; ø16mm	21191-137	EUDAMED	Class IIb	Active

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