EC DECLARATION OF CONFORMITY

Transcription

1 EC DECLARATION OF CONFORMITY No.: 11 (UMDNS ) valid to Manufacturer: BOWA-electronic GmbH & Co.KG Street and House No.: Heinrich-Hertz-Str Postal code and City: Gomaringen State/Federal State: Germany This declaration of conformity is issued under our sole responsibility (manufacturer). Object of declaration (identification of product allowing traceability): GMDN code and name: P Electrosurgical diathermy system electrode, active, reusable UMDNS code and name: Zange, Elektrochirurgie Category code and category: 04 Electrical and mechanical medical devices Classification rule and class: Rule 9 - Class IIb Product name: - see attached list - Model-/Order No.: - see attached list - The object of the declaration described above is in conformity with the relevant Community harmonisation legislation: Directive(s)_Date of last revision: Conformity assessment procedure: CD 93/42/EEC (MD)_ CD 2011/65/EU (RoHS)_ Annex II (Full Qualtity Assurance System) of CD 93/42/EEC (MD) Relevant standards: DIN EN : A1: A2:2010 DIN EN :2010 DIN EN 1041:2008 DIN EN ISO :2009 DIN EN ISO 14971:2007 The notified body TUEV SUED Product Service GmbH, Ridlerstr. 65, D München, identification number 0123, performed and issued the certificate(s): Title of Certificate: EC Certificate Full Quality Assurance System Certificate No., issued on: G , , valid to Certificate EN-13485:2012/AC:2012 No.: Q1N , , valid to Place, date of issue: Gomaringen, Name, function and signature: Frank Barth, Head of Quality Management

2 UMDNS-Code: DIMDI-notification number: DE/CA48/BOW-GO-006 "Monopolar + bipolar forceps, LAP instruments, ligation Instruments + bipolar scissors" ( monopolare + bipolare Pinzetten, LAP-Instrumente, Ligations-Instrumente + bipolare Scheren ) Order No. Product name Bipolar forceps, angled, 195 mm, 8 mm x 1 mm Bipolar forceps, bayonet, 195 mm, 6 mm x 1 mm Bipolar forceps, angled, 195 mm, 8 mm x 2 mm Bipolar forceps, straight, 160 mm, 6 mm x needle Bipolar forceps, angled, 160 mm, 6 mm x 0.5 mm Bipolar forceps, angled, 160 mm, 6 mm x 1 mm Bipolar forceps, bayonet, 165 mm, 6 mm x 1 mm Bipolar forceps, straight, 110 mm, 6 mm x needle Bipolar forceps, straight, 110 mm, 6 mm x 0.5 mm Bipolar forceps, angled, 110 mm, 6 mm x 0.5 mm Bipolar forceps, angled, 110 mm, 6 mm x needle Bipolar forceps, angled, 220 mm, 8 mm x 1 mm Bipolar forceps, straight, 160 mm, 8 mm x 2 mm Bipolar forceps, straight, 195 mm, 8 mm x 2 mm Bipolar forceps, straight, 220 mm, 8 mm x 2 mm Bipolar forceps, bayonet, 220 mm, 6 mm x 0.5 mm Bipolar forceps, bayonet, 165 mm, 6 mm x 0.5 mm Bipolar forceps, bayonet, 195 mm, 8 mm x 2 mm Bipolar forceps, angled, 160 mm, 6 mm x needle Bipolar forceps, straight, 160 mm, 8 mm x 1 mm Bipolar forceps, straight, 195 mm, 8 mm x 1 mm Bipolar forceps, straight, 220 mm, 8 mm x 1 mm Bipolar forceps, straight, 195 mm, 8 mm x 2 mm, square riffle Bipolar forceps, angled, 195 mm, 8 mm x 2 mm, square riffle Bipolar forceps, bayonet, 195 mm, 8 mm x 2 mm, square riffle Bipolar forceps, bayonet, angled, 220 mm, 6 mm x 1 mm Bipolar forceps, straight, 300 mm, 8 mm x 2 mm Bipolar forceps, straight, 270 mm, 8 mm x 2 mm Bipolar forceps, NON-Stick-Gold, angled, 195 mm x 8 mm x 1 mm Bipolar forceps, NON-Stick-Gold, bayonet, 195 mm x 6 mm x 1 mm Bipolar forceps, NON-Stick-Gold, angled, 195 mm x 8 mm x 2 mm Bipolar forceps, NON-Stick-Gold, angled, 160 mm x 6 mm x 1 mm Bipolar forceps, NON-Stick-Gold, straight, 110 mm x 6 mm x 0.5 mm

3 Bipolar forceps, NON-Stick-Gold, angled, 110 mm x 6 mm x 0.5 mm Bipolar forceps, NON-Stick-Gold, straight, 160 mm x 8 mm x 2 mm Bipolar forceps, NON-Stick-Gold, straight, 195 mm x 8 mm x 2 mm Bipolar forceps, NON-Stick-Gold, straight, 220 mm x 8 mm x 2 mm Bipolar forceps, NON-Stick-Gold, straight, 160 mm x 8 mm x 1 mm Bipolar forceps, NON-Stick-Gold, straight, 195 mm x 8 mm x 1 mm Bipolar forceps, NON-Stick-Gold, straight, 270 mm x 8 mm x 2 mm Monopolar forceps, bayonet, 195 mm, 8 mm x 2 mm Monopolar forceps, straight, 195 mm, 8 mm x 2 mm Monopolar forceps, straight, 195 mm, 8 mm x 1 mm Monopolar forceps, straight, 220 mm, 8 mm x 2 mm Monopolar forceps, straight, 220 mm, 8 mm x 1 mm Monopolar forceps, straight, 270 mm, 8 mm x 2 mm Monopolar forceps, anatomic, 180 mm, 18 mm x 2 mm Monopolar forceps, anatomic, 200 mm, 18 mm x 2.2 mm Monopolar forceps, anatomic, 245 mm, 18 mm x 2.4 mm Monopolar forceps, surgical, 180 mm, 18 mm x 2 mm Monopolar forceps, surgical, 210 mm, 18 mm x 2.2 mm Monopolar forceps, surgical, 250 mm, 18 mm x 2.4 mm ErgoLAP MONOPOLAR, handle ErgoLAP MONOPOLAR, jaw, forceps, 360 mm ErgoLAP MONOPOLAR, jaw, DeBakey, 360 mm ErgoLAP MONOPOLAR, jaw, Babcock, 360 mm ErgoLAP MONOPOLAR, jaw, Metzenbaum, 360 mm ErgoLAP MONOPOLAR, jaw, hook scissors, 360 mm ErgoLAP MONOPOLAR, jaw, Dorsey, 360 mm ErgoLAP MONOPOLAR, jaw, Fundus, 360 mm ErgoLAP MONOPOLAR, jaw, Maryland, 360 mm ErgoLAP MONOPOLAR, jaw, Alligator, 360 mm ErgoLAP MONOPOLAR, shaft tube, 360 mm ErgoLAP MONO., handle, shaft tube, sealing spare parts, 360 mm ErgoLAP BIPOLAR, handle ErgoLAP BIPOLAR, handle, shaft tube, sealing spare parts, 330 mm ErgoLAP BIPOLAR, jaw, Hirsch, 330 mm ErgoLAP BIPOLAR, jaw, Kleppinger, 330 mm ErgoLAP BIPOLAR, jaw, tweezers, 330 mm ErgoLAP BIPOLAR, jaw, micro-tweezers, 330 mm ErgoLAP BIPOLAR, outer shaft tube, 330 mm ErgoLAP BIPOLAR, inner shaft tube, 330 mm TissueSeal handle, 190 mm

4 TissueSeal handle, 230 mm TissueSeal handle, 280 mm ErgoLAP BIPOLAR, jaw, NON-Stick CUT, knife-shaped, 330 mm TissueSeal PLUS, 190 mm TissueSeal PLUS, 230 mm TissueSeal PLUS, 280 mm TissueSeal PLUS COMFORT, 160 mm TissueSeal PLUS COMFORT, 190 mm TissueSeal PLUS COMFORT, 230 mm TissueSeal PLUS COMFORT, 280 mm TissueSeal COMFORT, 190 mm, cable 4.5 m TissueSeal COMFORT, 230 mm, cable 4.5 m TissueSeal COMFORT, 280 mm, cable 4.5 m ErgoLAP BIPOLAR, jaw, NON-Stick CUT, wedge-shaped, 330 mm NightKNIFE + LIGATOR, handle Bipolar handle LIGATOR, handle, shaft tube, sealing spare parts, 360 mm NightKNIFE, handle, shaft tube, jaw, 200 mm NightKNIFE, handle, shaft tube, jaw, exchangeable knife, 200 mm LIGATOR, shaft tube, 110 mm LIGATOR, shaft tube, 360 mm NightKNIFE, handle, shaft tube, jaw, 360 mm NightKNIFE, handle, shaft tube, jaw, exchangeable knife, 360 mm NightKNIFE, shaft tube, 200 mm NightKNIFE, shaft tube, 360 mm NightKNIFE, blade (5 pcs.) LIGATOR, jaw, straight, 110 mm LIGATOR, jaw, straight, 360 mm NightKNIFE, jaw, 200 mm NightKNIFE, jaw, exchangeable knife, 200 mm NightKNIFE, jaw, 360 mm NightKNIFE, jaw, exchangeable knife, 360 mm LIGATOR, jaw, Maryland, 110 mm LIGATOR, jaw, Maryland, 360 mm NightKNIFE + LIGAOTR set NightKNIFE + LIGATOR set (exchangeable knife) BiZZER, bipolar scissors, 145 mm, curved, needle tip BiZZER, bipolar scissors, 180 mm, curved, needle tip BiZZER, bip. scissors, 145 mm, curved, needle tip, COMFORT, cable 4.5m BiZZER, bip. scissors, 180 mm, curved, needle tip, COMFORT, cable 4.5m

5 BiZZER, bipolar scissors, 170 mm, curved BiZZER, bipolar scissors, 170 mm, curved, COMFORT, cable 4.5 m BiZZER, bipolar scissors, 180 mm, curved, slight BiZZER, bipolar scissors, 230 mm, curved, slight BiZZER, bipolar scissors, 280 mm, curved, slight BiZZER, bipolar scissors, 180 mm, curved, slight, COMFORT, cable 4.5 m BiZZER, bipolar scissors, 230 mm, curved, slight, COMFORT, cable 4.5 m BiZZER, bipolar scissors, 280 mm, curved, slight, COMFORT, cable 4.5 m BiZZER, bipolar scissors, 145 mm, curved, fine BiZZER, bipolar scissors, 180 mm, curved, fine BiZZER, bipolar scissors, 230 mm, curved, fine BiZZER, bipolar scissors, 280 mm, curved, fine BiZZER, bipolar scissors, 145 mm, curved, fine, COMFORT, cable 4.5 m BiZZER, bipolar scissors, 180 mm, curved, fine, COMFORT, cable 4.5 m BiZZER, bipolar scissors, 230 mm, curved, fine, COMFORT, cable 4.5 m BiZZER, bipolar scissors, 280 mm, curved, fine, COMFORT, cable 4.5 m