EG-Konformitätserklärung EC Declaration of Conformity Anbieter: Name: Geister Medizintechnik GmbH Anschrift: Föhrenstrasse 2 Address: 78532 Tuttlingen / Germany Produkte: Chirurgische Instrumente Klasse IIa Producte: Medical devices Class IIa Artikel: Siehe Produktliste im Anhang Article: See Product List in the Annex Wir erklären in alleiniger Verantwortung, dass die oben aufgeführten Medizinprodukte den einschlägigen Bestimmungen der Richtlinie 93/42/EWG entsprechen. We declare on our own responsibility that the medical devices specified above, meets all the provisions of the Directive 93/42/EEC which apply for him. Die Erklärung gilt für alle Produkte des angegebenen Typs bis zum 31.12.2019. This declaration concerns all denoted medical devices until the date 31.12.2019. Angewandtes Konformitätsbewertungsverfahren nach Richtlinie 93/42/EWG: Conformity assessment procedure according Directive 93/42/EEC: Ausgabe/ Dokument-Nr. Titel Ausgabedatum Document No Title Date of issue Richtlinie 93/42/EWG des Rates über Medizinprodukte 93/42/EWG Directive 93/42/EEC for Medical Devices 14.06.1993 93/42/EEC Annex II.3 , Annex V , Annex VII Benannte Stelle / Notified Body: TÜV SÜD Product Service GmbH, Zertifizierstelle, Ridlerstrasse 65, 80339 München / Germany Kennnummer / Reg.-No: 0123 Tuttlingen, 02.01.2015 Carsten Geister, General Manager (Name, Funktion) (Unterschrift) (Name and Function) (Sign) Filename with change level: Created / Changed at: Edited by: Page DoC Cl IIa J_Product List 02.01.15 jw 1 to 24 Item Article designation Class 01-1550 01-1550 Buchmeister Retractor Kit II IIa 18-0050 ValveGate™ Cardioplegia Needle IIa 18-0051 ValveGate™ Cardioplegia Needle IIa 18-0099 Heparin Flushing Needle IMA, 2.0mm 4.5c IIa 18-0100 Heparin Flushing Needle #1, 3.0mm 4.5cm IIa 18-0102 Heparin Flushing Needle #2, 3.7mm 5.5cm IIa 18-0104 Heparin Flushing Needle #3, 5.0mm 16cm IIa 18-0110 Hajek Suction Cannula Silver 16.5cm IIa 18-0188 Southhampton Peadiatric Suction Tube IIa 18-0188.30 Southhampton Peadiatric Suction Tube IIa 18-0189 Southhampton Peadiatric Suction Tube IIa 18-0189.SP Southhampton Peadiatric Suction Tube Tip IIa 18-0190 Brompton Suction Tube for children IIa 18-0190.SP Brompton Suction Spare tip only IIa 18-0200 DeBakey Suction Tube 9mm tip, 28cm IIa 18-0205 Morse-Andrews Suction Tube 26cm IIa 18-0205.SP Morse-Andrews Suction Tube 26cm - tip IIa 18-0212 Senning Suction Tube 8mm basket tip 31cm IIa 18-0220 Cooley Suction Tube 8mm tip, 35cm IIa 18-0222 Cooley Suction Tube 8mm tip, 31cm IIa 18-0223 Cooley Suction Tube 9mm tip, 30cm IIa 18-0224 Cooley Suction Tube 8mm tip, 33cm IIa 18-0225 Cooley Suction Tube 8mm tip, 25cm IIa 18-0228 Andrew-Pynchon Suction Tube 24cm IIa 18-0229 Anthony Suction Tube 4mm 12Ch. IIa 18-0230 Yankauer Suction Tube 27cm IIa 18-0230.KO Luer-Cone for Yankauer Suction Tube IIa 18-0230.SP Tip for Yankauer Suction Tube IIa 18-0231 Baby-Yankauer Suction Tube 27cm IIa 18-0232 Baby-Yankauer Suction Tube 21cm IIa 18-0232.SP Tip for Baby-Yankauer Suction Tube IIa 18-0233 Braun Ralph Suction Tube 30cm 7mm flute IIa 18-0233.SP Tip for Braun Ralph Suction Tube IIa 18-0234 Osaka Suction Tube heavy 27cm 7mm IIa 18-0235 Harley Street Suction Tube IIa 18-0235.SP Tip only for Harley Street Suction Tube IIa 18-0236 Hammersmith Suction Tube smal IIa 18-0237 Hammersmith Suction Tube medium 1/4" IIa 18-0240 Poole Suction 23.5cm 10mm IIa 18-0240.GB Poole Suction 23.5cm 10mm cvd. IIa 18-0241 Poole Suction 20cm 6mm IIa 18-0242 Poole Suction 24.5cm 8mm angled conn. IIa 18-0243 Poole Suction 22cm 6mm Anschluss geb IIa 18-0244 Yankauer Suction Tube with control IIa 18-0260 Magill Suction Tube with ring 3mm 21cm IIa 18-0261 Magill Suction Tube with ring 3.5mm 21cm IIa 18-0262 Magill Suction Tube with ring 4mm 21cm IIa 18-0280 Tibbs Suction Tube small olive IIa 18-0281 Tibbs Suction Tube small conus IIa 18-0282 Tibbs Suction Tube large olive IIa 18-0283 Tibbs Suction Tube large conus IIa 18-0284 Tibbs Suction Tube Set (4) IIa 18-0300 Baylor Sump Tube 90° 5mm IIa 18-0301 Baylor Sump Tube 45° 5mm IIa 18-0305 Baylor Sump Tube 90° 4mm IIa 18-0306 Baylor Sump Tube 45° 4mm IIa Filename with change level: Created / Changed at: Edited by: Page DoC Cl IIa J_Product List 02.01.15 jw 2 to 24 18-0310 Baylor Vena Cava Cannula 4mm IIa 18-0320 Ice Water Sucker IIa 18-0370 ThoraGate™ Saugrohr Ø 3,2mm, 31cm IIa 18-0370.SU ThoraGate™ Saugrohr Ø 3,2mm, 31cm IIa 18-0371 ThoraGate™ Saugrohr Ø 3,2mm, 36cm IIa 18-0371.SU ThoraGate™ Saugrohr Ø 3,2mm, 36cm IIa 18-0375 ThoraGate™ Saugrohr Ø 5,0mm, 36cm IIa 18-0375.SU ThoraGate™ Saugrohr Ø 5,0mm, 36cm IIa 18-0376 ThoraGate™ Saugrohr Ø 5,0mm, 45,5cm IIa 18-0376.SU ThoraGate™ Saugrohr Ø 5,0mm, 45,5cm IIa 18-0380 ThoraGate™ Saugrohr Ø 5,0mm, 45,5cm IIa 18-0380.SU ThoraGate™ Saugrohr Ø 5,0mm, 45,5cm IIa 18-0381 ThoraGate™ Saugrohr Ø 10,0mm, 45,5cm IIa 18-0381.SU D'Amico Saugrohr Ø 10,0mm, 45,5cm IIa 18-0400 Bugge™ Suction Tube large IIa 18-0402 Bugge™ Suction Tube medium IIa 18-0404 Bugge™ Suction Tube small IIa 18-0406 Bugge™ Suction Tube mini IIa 18-0408 Bugge™ Suction Tube micro IIa 18-0410L Jennie's Suction 23cm left IIa 18-0410R Jennie's Suction 23cm right IIa 18-0420 Jamieson Dissection Sucker and Plaque IIa 18-0425 Pediatric Suction Tube 3.0mm 21cm IIa 18-0426 Pediatric Suction Tube 4.0mm 22.5cm IIa 18-0427 Pediatric Suction Tube 4.0mm 24.5cm IIa 18-0430 HLM Suction with long basket 28cm 6.9mm IIa 18-1002 Yasargil Suction Cannula 13cm 1.5mm IIa 18-1004 Yasargil Suction Cannula 15cm 1.5mm IIa 18-1006 Yasargil Suction Cannula 18cm 1.5mm IIa 18-1008 Yasargil Suction Cannula 22cm 1.5mm IIa 18-1012 Yasargil Suction Cannula 13cm 2.0mm IIa 18-1014 Yasargil Suction Cannula 15cm 2.0mm IIa 18-1016 Yasargil Suction Cannula 18cm 2.0mm IIa 18-1018 Yasargil Suction Cannula 22cm 2.0mm IIa 18-1022 Yasargil Suction Cannula 13cm 2.5mm IIa 18-1024 Yasargil Suction Cannula 15cm 2.5mm IIa 18-1026 Yasargil Suction Cannula 18cm 2.5mm IIa 18-1028 Yasargil Suction Cannula 22cm 2.5mm IIa 18-1032 Yasargil Suction Cannula 13cm 3.5mm IIa 18-1034 Yasargil Suction Cannula 15cm 3.5mm IIa 18-1036 Yasargil Suction Cannula 18cm 3.5mm IIa 18-1038 Yasargil Suction Cannula 22cm 3.5mm IIa 18-1046 Yasargil Suction Cannula 18cm 4.5mm IIa 18-4020 Frazier 17cm D=2.0mm Charr. 6 straight IIa 18-4021 Frazier 17cm D=2.7mm Charr. 8 straight IIa 18-4022 Frazier 17cm D=3.3mm Charr. 10 straight IIa 18-4023 Frazier 17cm D=4.0mm Charr. 12 straight IIa 18-4030 Frazier 13cm D=2.0mm Charr. 6 angled IIa 18-4031 Frazier 13cm D=2.7mm Charr. 8 angled IIa 18-4032 Frazier 13cm D=3.3mm Charr. 10 angled IIa 18-4033 Frazier 13cm D=4.0mm Charr. 12 angled IIa 18-4040 Frazier 17cm D=2.0mm Charr. 6 angled IIa 18-4041 Frazier 17cm D=2.7mm Charr. 8 angled IIa 18-4042 Frazier 17cm D=3.3mm Charr. 10 angled IIa 18-4043 Frazier 17cm D=4.0mm Charr. 12 angled IIa 18-4044 Frazier 17cm D=5.0mm Charr. 15 angled IIa 18-4060 Frazier 17cm D=2.0mm Charr. 6 angled 90° IIa 18-4061 Frazier 17cm D=2.7mm Charr. 8 angled 90° IIa Filename with change level: Created / Changed at: Edited by: Page DoC Cl IIa J_Product List 02.01.15 jw 3 to 24 18-4062 Frazier 17cm D=3.3mm Charr. 10 angled IIa 18-4063 Frazier 17cm D=4.0mm Charr. 12 angled IIa 18-4065 Adson Suction Tube curved 12Fr. 20.5cm IIa 18-4070 DeBakey-Adson Coronary Suction Tube 20cm IIa 18-4072 DeBakey-Adson Coronary Suction Tube 16cm IIa 18-4080 Pflester Saugrohr Ø 1,5mm, Charr.5 IIa 18-4081 Pflester Saugrohr Ø 2,0mm, Charr.6 IIa 18-4082 Pflester Saugrohr Ø 2,5mm, Charr.7 IIa 18-4083 Pflester Saugrohr Ø 3,0mm, Charr.9 IIa 18-4469 Reducer 5/8"->1/2" (16->12mm) IIa 18-4470 Reducer 5/8"->3/8" (16->9mm) IIa 18-4471 Reducer 1/2"->3/8" (12->9mm) IIa 18-4472 Reducer 1/2"->1/4" (12->6mm) IIa 18-4473 Reducer 3/8"->1/4" (9->6mm) IIa 18-4474 Reducer 1/4"->3/16" (6->4.7mm) IIa 18-4475 Reducer 1/4"->1/8" (6->3mm) IIa 18-4476 Reducer 5/16"->1/4" (8->6mm) IIa 18-4500 Ross Atrial Basket L=29mm 1/2" IIa 18-4501 Ross Atrial Basket L=29mm 3/8" IIa 18-4502 Ross Atrial Basket L=19mm 3/8" IIa 18-4503 Ross Atrial Basket L=16mm 1/4" IIa 18-4505 Ross Sump Sucker Adult IIa 18-4506 Ross Sump Sucker Child IIa 18-4507 Ross Sump Sucker Infant IIa 18-4510 Ormond Ventricular Drain 10mm 1/8" IIa 18-4511 Ormond Ventricular Drain 18mm 3/16" IIa 18-4520 Ross Ventricular Vent, Adult IIa 18-4521 Ross Ventricular Vent, Child IIa 18-4522 Ross Ventricular Vent, Infant IIa 18-4530 Heavy Bullet Vent 14x56mm, 6mm IIa 18-4540 Double Lumen Bullet Vent IIa 18-4550 Aortic Vent Needle 18ga.