Question 1

What types of medical devices does Medical Wire & Equipment Co Bath (Ltd) manufacture?

Accepted Answer

Medical Wire & Equipment Co Bath (Ltd) specializes in swab collection devices for clinical and laboratory use. Their portfolio includes dry fecal swabs (like the U-SWAB™ FECAL DRY), viral transport swabs, and swabs for collecting and transporting specimens such as nasopharyngeal, oropharyngeal, and rectal samples. These devices are designed for diagnostic, screening, and monitoring purposes in healthcare settings, supporting both infectious disease testing and general specimen collection.

Question 2

Where is Medical Wire & Equipment Co Bath (Ltd) based?

Accepted Answer

The company is based in the United Kingdom, specifically in Bath. This location places it within the European Economic Area, where it operates under the regulatory framework for medical devices and in vitro diagnostics (IVDs) applicable to the region.

Question 3

Which regulatory registries list the devices produced by Medical Wire & Equipment Co Bath (Ltd)?

Accepted Answer

The company’s devices are registered in the EUDAMED database, which is the European Union’s medical device registry. This platform is used to track and provide transparency on medical devices and IVDs authorized within the European Economic Area, ensuring compliance with EU Medical Device Regulations.

Question 4

How are the devices manufactured by Medical Wire & Equipment Co Bath (Ltd) classified under EU regulations?

Accepted Answer

The company’s devices fall under various classification categories within the EU Medical Device Regulations, including Class A, Class I, Class IIa, and In Vitro Diagnostic (IVD) General. The classification depends on factors like the intended use, risk level, and the type of specimen collection or diagnostic purpose, ensuring appropriate regulatory oversight and compliance.

Device	Model / Reference	Registries	Class	Status
Wire microloop	MW195	EUDAMED	Class A	Active
Dryswab	MW1028D	EUDAMEDFDA UDI	Class I	Active
Sigma Swab	MW946	EUDAMEDFDA UDI	Class I	Active
Sigma Transwab	MW176S3	EUDAMEDFDA UDI	Class IIa	Active
Sigma Virocult	MW951SE23ML	EUDAMEDFDA UDI	Class I	Active
Wire microloop	MW197	EUDAMED	Class A	Active
Dryswab	MW943	EUDAMEDFDA UDI	Class I	Active
Sigma Transwab	MW176S2ML	EUDAMEDFDA UDI	Class IIa	Active
Dryswab	MW142	EUDAMEDFDA UDI	Class I	Active
Dryswab	MW822	EUDAMED	Class I	Active
Sigma virocult	501351	EUDAMEDFDA UDI	Class I	Active
Dryswab	MW108/5	EUDAMEDFDA UDI	Class I	Active
Sigma Transwab	Mw176S	EUDAMEDFDA UDI	Class IIa	Active
Sigma Swab	MW945	EUDAMED	Class I	Active
Transwab	MW165C	EUDAMEDFDA UDI	Class IIa	Active
Dryswab	MW151D	EUDAMEDFDA UDI	Class I	Active
Sigma Virocult	MW950S2	EUDAMEDFDA UDI	Class I	Active
Dryswab	MW011	EUDAMEDFDA UDI	Class I	Active
Dryswab	MW100	EUDAMEDFDA UDI	Class I	Active
Molecular Medium	MWMM	EUDAMED	IVD General	Active
Dryswab	MW010	EUDAMEDFDA UDI	Class I	Active
Amnicator	MWAM5	EUDAMEDFDA UDI	Class I	Active
Dryswab	MW130	EUDAMEDFDA UDI	Class I	Active
Wire microloop	MW191	EUDAMED	Class A	Active
Fecal Transwab	MW168T	EUDAMED	IVD General	Active
U-Swab™ Fecal	M200146	EUDAMED	IVD General	Active
Sigma Transwab	MW177HF	EUDAMED	Class I	Active
Sigma VCM	MW911S	EUDAMED	Class I	Active
Cytotak	MW148	EUDAMED	Class I	Active
Cytotak	MW147	EUDAMEDFDA UDI	Class I	Active
Sigma Virocult	MW951SENT	EUDAMEDFDA UDI	Class I	Active
Sigma Transwab	M350110	EUDAMED	Class I	Active
Dryswab	MW840	EUDAMED	Class I	Active
Dryswab	MW820	EUDAMED	Class I	Active
Dryswab	MW814	EUDAMED	Class I	Active
Dryswab	MW810	EUDAMED	Class I	Active
Molecular medium	MWMM200	EUDAMED	IVD General	Active
Sigma VCM	MW924S	EUDAMED	Class I	Active
Sigma VCM	MW913PF2ML	EUDAMED	Class I	Active
Sigma Transwab	MW176PF	EUDAMED	Class IIa	Active
Dryswab	MW108	EUDAMEDFDA UDI	Class I	Active
Transwab	MW166C	EUDAMEDFDA UDI	Class IIa	Active
Transwab	MW173P	EUDAMEDFDA UDI	Class I	Active
Dryswab	MW015	EUDAMEDFDA UDI	Class I	Active
Dryswab	MW012	EUDAMEDFDA UDI	Class I	Active
Sigma Transwab	501005	EUDAMEDFDA UDI	Class I	Active
Sigma Virocult	MW952H23ML	EUDAMED	Class I	Active
Medical Wire & Equipment Co (bath) Ltd	MW170	EUDAMEDFDA UDI	Class IIa	Active
Sigma Transwab	MW176SE23ML	EUDAMEDFDA UDI	Class IIa	Active
Sigma Transwab	MW177S2ML	EUDAMEDFDA UDI	Class I	Active

Medical Wire & Equipment Co Bath (Ltd)

What Medical Wire & Equipment Co Bath (Ltd) makes

Frequently asked questions

Information

Catalogue (147)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities

FDA Establishments (1)