FDA Medical Device Classification

Declaration of Compliance

FDA Listings

Pursuant to Section 13 (2) of the Act no. 22/1997 Coll. on Technical Requirements for Devices and Amendments and Supplements to Certain Acts, as amended, and pursuant to Section 14 of the Government’s Order no. 181/2001 Coll. by means of which Technical Requirements for Medical Technology are defined, as amended Manufacturer ID no.25328204 Tax Ident. no. 005-25328204 hereby confirms that the medical device:

name: The Bauer Bandage® class: IIb

was assessed in respect to compliance of its characteristics with the requirements for the product’s safety prescribed by the law and the technical regulations and it declares that the characteristics of the above mentioned medical device comply with all basic requirements prescribed by DIRECTIVE 93/42/EEC and the medical device is safe for the determined purpose under common conditions.

The Bauer Bandage® is designated as a disposable product.

Manufacturer  has taken measures through which it secures compliance of the medical device which is being introduced to the market with its technical documentation and the basic requirements.

Description of the medical device, purpose of its use

The Bauer Bandage® is indicated for treatment of trophic wounds, ulcerous lesions, suppurative areas of various etiology, complicated post-operative wounds with bacterial contamination and for elimination of unpleasant odour.

During the assessment of compliance the following regulations were applied:

Applied regulations

The method pursuant to Council Directive 93/42/EEC and specifications of ANNEX II was applied to the assessment of the elementary characteristics of the produced in the prescribed manner.

FDA Classification : Class I ( general controls ) Code : E 878.4018 Listing number: E171163

The following authorized entity contributed to the assessment of compliance:

Medical Devices Lead Auditor
SGS UK Ltd CE 0120
Prague , April 1st, 2003 Vaclav Bauer (director)

FDA Listings