Question 1

What types of medical devices does Chemische Fabrik Dr. Weigert GmbH & Co. KG manufacture?

Accepted Answer

Chemische Fabrik Dr. Weigert GmbH & Co. KG specializes in cleaning and maintenance solutions for medical devices. Their portfolio includes dishwasher detergents, medical device cleaning agents, instrument rinsing agents, disinfection agents, and surgical instrument maintenance lubricants. These products are designed to support sterilization processes and ensure proper hygiene in healthcare environments.

Question 2

Where is Chemische Fabrik Dr. Weigert GmbH & Co. KG based?

Accepted Answer

The company is based in the United States. While the name suggests a German origin, their operations and regulatory compliance are conducted within the US market, where they develop and distribute their medical device-related cleaning and maintenance solutions.

Question 3

Which regulatory registries list the devices manufactured by Chemische Fabrik Dr. Weigert GmbH & Co. KG?

Accepted Answer

The devices produced by Chemische Fabrik Dr. Weigert GmbH & Co. KG are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and compliance tracking for Class I medical devices, including their cleaning agents, disinfectants, and maintenance solutions.

Question 4

How are the devices produced by Chemische Fabrik Dr. Weigert GmbH & Co. KG classified under medical device regulations?

Accepted Answer

The devices manufactured by Chemische Fabrik Dr. Weigert GmbH & Co. KG are classified as Class I medical devices. This classification applies to substances like cleaning agents, disinfectants, and lubricants used in medical device maintenance, as they pose minimal risk when used as intended in healthcare settings.

Device	Model / Reference	Registries	Class	Status
ProCare Dent 30 P	4029577143510	FDA UDI	Class I	Unknown
neodisher MediClean forte	4029577154257	FDA UDI	Class I	Active
neodisher MultiZym	4029577152703	FDA UDI	Class I	Active
ProCare Dent 30 C	4029577158224	FDA UDI	Class I	Active
ProCare Dent 10 MA	4029577158200	FDA UDI	Class I	Active
neodisher MultiZym	4029577156954	FDA UDI	Class I	Active
ProCare Dent 30 P	4029577158231	FDA UDI	Class I	Active
ProCare Dent 30 C	4029577155032	FDA UDI	Class I	Unknown
ProCare Dent 11 A	4029577143459	FDA UDI	Class I	Unknown
ProCare Dent 40	4029577158248	FDA UDI	Class I	Active
ProCare Dent 11 A	4029577143442	FDA UDI	Class I	Unknown
neodisher MediKlar	4029577155155	FDA UDI	Class I	Unknown
ProCare Dent 30 P	4029577155087	FDA UDI	Class I	Unknown
neodisher MultiZym	4029577151478	FDA UDI	Class I	Active
ProCare Dent 30 P	4029577155094	FDA UDI	Class I	Unknown
neodisher FA	4029577122171	FDA UDI	Class I	Active
ProCare Dent 10 MA	4029577154967	FDA UDI	Class I	Unknown
ProCare Dent 10 MA	4029577143435	FDA UDI	Class I	Unknown
neodisher MediClean forte	4029577154837	FDA UDI	Class I	Active
ProCare Dent 40	4029577143527	FDA UDI	Class I	Unknown
neodisher SeptoClean	4029577150631	FDA UDI	Class I	Active
Procare Dent 10 A	4029577158194	FDA UDI	Class I	Active
neodisher N	4029577121464	FDA UDI	Class I	Active
neodisher N	4029577121471	FDA UDI	Class I	Active
ProCare Dent 40	4029577158255	FDA UDI	Class I	Active
neodisher MediClean forte	4029577154240	FDA UDI	Class I	Active
neodisher MultiZym	4029577156961	FDA UDI	Class I	Active
neodisher MediZym	4029577145101	FDA UDI	Class I	Active
neodisher PreStop	4029577151454	FDA UDI	Class I	Active
neodisher MA	4029577121921	FDA UDI	Class I	Active
ProCare Dent 11 A	4029577154998	FDA UDI	Class I	Unknown
ProCare Dent 30 C	4029577143480	FDA UDI	Class I	Unknown
neodisher Z	4029577121532	FDA UDI	Class I	Active
ProCare Dent 10 MA	4029577143428	FDA UDI	Class I	Unknown
ProCare Dent 11 A	4029577158217	FDA UDI	Class I	Active
neodisher Z	4029577121525	FDA UDI	Class I	Active
ProCare Dent 10 A	4029577143398	FDA UDI	Class I	Unknown
ProCare Dent 30 P	4029577143503	FDA UDI	Class I	Unknown
ProCare Dent 30 C	4029577155049	FDA UDI	Class I	Unknown
neodisher Mielclear	4029577140724	FDA UDI	Class I	Unknown
ProCare Dent 30 P	4029577143497	FDA UDI	Class I	Unknown
neodisher MediClean forte	4029577154844	FDA UDI	Class I	Active
neodisher MediKlar	4029577154851	FDA UDI	Class I	Unknown
neodisher FA	4029577154264	FDA UDI	Class I	Active
ProCare Dent 30 C	4029577143466	FDA UDI	Class I	Unknown
ProCare Dent 30 C	4029577143473	FDA UDI	Class I	Unknown

Chemische Fabrik Dr. Weigert GmbH & Co. KG

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