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
U-Swab™ Fecal Dry	M200147	EUDAMED	IVD General	Active
Dryswab	MW817	EUDAMED	Class I	Active
Sigma Virocult	MW951SE2	EUDAMEDFDA UDI	Class I	Active
Transwab	MW168	EUDAMED	Class I	Active
Sigma VCM	MW910S3ML	EUDAMED	Class I	Active
Dryswab	Mw112/2D	EUDAMEDFDA UDI	Class I	Active
Transwab	MW165P	EUDAMEDFDA UDI	Class IIa	Active
Sigma Transwab	MW176SE2	EUDAMEDFDA UDI	Class IIa	Active
Sigma Transwab	350022	EUDAMED	Class IIa	Active
Sigma Transwab	501001	EUDAMEDFDA UDI	Class IIa	Active
Sigma Virocult	MW951PF2ML	EUDAMED	Class I	Active
sigma Virocult	MW951S3ML	EUDAMEDFDA UDI	Class I	Active
Dryswab	MW155	EUDAMEDFDA UDI	Class I	Active
Sigma SP	MWSP	EUDAMED	IVD General	Active
Sigma Virocult	MW951S2	EUDAMEDFDA UDI	Class I	Active
Dryswab	MW108/20	EUDAMEDFDA UDI	Class I	Active
Microloop	MW7001	EUDAMED	IVD General	Active
Dryswab	325001	EUDAMEDFDA UDI	Class I	Active
Transwab	MW169P	EUDAMEDFDA UDI	Class IIa	Active
Sigma Swab	MW944	EUDAMEDFDA UDI	Class I	Active
Transwab	MW172C	EUDAMEDFDA UDI	Class I	Active
Dryswab	MW108/2	EUDAMEDFDA UDI	Class I	Active
Dryswab	325003	EUDAMEDFDA UDI	Class I	Active
Sigma Swab	MW941	EUDAMEDFDA UDI	Class I	Active
Wire microloop	MW1871	EUDAMED	Class A	Active
Sigma Virocult	MW950S3ML	EUDAMEDFDA UDI	Class I	Active
Sigma Virocult	MW950SE2	EUDAMEDFDA UDI	Class I	Active
Dryswab	MW113	EUDAMEDFDA UDI	Class I	Active
Sigma VCM	MW911PF	EUDAMED	Class I	Active
Molecular Medium	MW250	EUDAMED	IVD General	Active
Dryswab	MW112D	EUDAMED	Class I	Active
Dryswab	MW013	EUDAMEDFDA UDI	Class I	Active
Sigma Virocult	MW950SENT	EUDAMEDFDA UDI	Class I	Active
Dryuswab	MW1028	EUDAMEDFDA UDI	Class I	Active
Dryswab	MW108/10	EUDAMEDFDA UDI	Class I	Active
U Swab Vaginal	M200101	EUDAMED	Class I	Active
Sigma Virocult	MW950S3B	EUDAMEDFDA UDI	Class I	Active
Sigma Virocult	MW951S	EUDAMEDFDA UDI	Class I	Active
Selenite Broth	MWSEL	EUDAMED	IVD General	Active
Mw916t	MW916T	EUDAMED	IVD General	Active
Microloop	MW7021	EUDAMED	IVD General	Active
Sigma VCM	MW910HF2ML	EUDAMED	Class I	Active
Sigma Transwab	MW167S	EUDAMEDFDA UDI	Class IIa	Active
Sigma Virocult	MW951S2ML	EUDAMEDFDA UDI	Class I	Active
Sigma VCM	MW910PF	EUDAMED	Class I	Active
Amnicator	MWAM2	EUDAMEDFDA UDI	Class I	Active
Trade Name	MW175P	EUDAMEDFDA UDI	Class IIa	Active
Wire microloop	MW195	EUDAMED	Class A	Active
Dryswab	MW1028D	EUDAMEDFDA UDI	Class I	Active
Sigma Swab	MW946	EUDAMEDFDA UDI	Class I	Active

Medical Wire & Equipment Co Bath (Ltd)

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