Customers and certificates

FUJIFILM medwork GmbH

Business Sector:
Other active non-implantable surgical devices, Non-active intruments, Non-active device for injection, infusion, transfusion and dialysis
Reference No.:
230521
Certified according to :
Scope:

MDN 1203 - Nichtaktive nichtimplantierbare Führungskatheter, Ballonkatheter, Führungsdrähte, Einführhilfen, Filter und damit zusammenhängende Instrumente - Steinextraktionsballon MDA 0312 - Sonstige aktive nichtimplantierbare Produkte für die Chirurgie -Polypektomieschlinge, Polypektomieschlinge mit Injektionsnadel MDN 1202 - Nichtaktive nichtimplantierbare Produkte zur Verabreichung, Leitung und Entfernung von Stoffen einschließlich Dialyseprodukten -Applikationskatheter MDN 1202 - Nichtaktive nichtimplantierbare Produkte zur Verabreichung, Leitung und Entfernung von Stoffen einschließlich Dialyseprodukten -ERCP-Katheter MDN 1202 - Nichtaktive nichtimplantierbare Produkte zur Verabreichung, Leitung und Entfernung von Stoffen einschließlich Dialyseprodukten -EUS-FNA Nadel, EUS-FNB Nadel MDN 1208 - Nichtaktive nichtimplantierbare Instrumente -Polypektomieschlinge, kalt MDA 0312 - Sonstige aktive nichtimplantierbare Produkte für die Chirurgie -Papillotome, Papillotome + Führungsdraht MDN 1203 - Nichtaktive nichtimplantierbare Führungskatheter, Ballonkatheter, Führungsdrähte, Einführhilfen, Filter und damit zusammenhängende Instrumente - Führungskatheter MDN 1203 - Nichtaktive nichtimplantierbare Führungskatheter, Ballonkatheter, Führungsdrähte, Einführhilfen, Filter und damit zusammenhängende Instrumente - Legesystem MDN 1203 - Nichtaktive nichtimplantierbare Führungskatheter, Ballonkatheter, Führungsdrähte, Einführhilfen, Filter und damit zusammenhängende Instrumente - Pusher MDN 1208 - Nichtaktive nichtimplantierbare Instrumente -Endoskopventil-Set

MDN 1203 - Non-active non-implantable guide catheters, balloon catheters, guidewires, introducers, filters, and related tools -Stone extraction balloon MDA 0312 - Other active non-implantable surgical devices -Polypectomy snare, Polypectomy snare with injection needle MDN 1202 - Non-active non-implantable devices for administration, channelling and removal of substances, including devices for dialysis -Application catheter MDN 1202 - Non-active non-implantable devices for administration, channelling and removal of substances, including devices for dialysis -ERCP-Catheter MDN 1202 - Non-active non-implantable devices for administration, channelling and removal of substances, including devices for dialysis -EUS-FNA needle, EUS-FNB needle MDN 1208 - Non-active non-implantable instruments -Polypectomy snare, cold MDA 0312 - Other active non-implantable surgical devices -Papillotome, Papillotome + guide wire MDN 1203 - Non-active non-implantable guide catheters, balloon catheters, guidewires, introducers, filters, and related tools -Guiding catheter MDN 1203 - Non-active non-implantable guide catheters, balloon catheters, guidewires, introducers, filters, and related tools -Delivery system MDN 1203 - Non-active non-implantable guide catheters, balloon catheters, guidewires, introducers, filters, and related tools -Pusher MDN 1208 - Non-active non-implantable instruments -Endoscope valve kit

Scope:

Confirmation Letter

Certified according to :
Scope:

Sterile: Design, Development, Manufacturing, Distribution of BILIARY BALLOON CATHETERS - HIGH PRESSURE, BILIARY TUBES, BRONCHOSCOPIC INSTRUMENTARY – OTHERS, DIGESTIVE ENDOSCOPY - HAEMOSTASIS CLIPS, DIGESTIVE ENDOSCOPY - MONOLUME NEEDLES, DIGESTIVE ENDOSCOPY - RETRIEVAL BALLOON DEVICES, DIGESTIVE ENDOSCOPY - - RETRIEVAL BASKET DEVICES - NON-REVOLVING / REVOLVING, DIGESTIVE ENDOSCOPY - RETRIEVAL DEVICES – OTHERS, ERCP CANNULAS - ONE-WAY - STANDARD TIP / TAPERED TIP/ OTHERS, ERCP CANNULAS - MORE WAYS - TAPERED TIP, ERCP AND SPHINCTEROTOMY DEVICES – OTHERS, GASTROINTESTINAL DEVICES – OTHERS, GASTROINTESTINAL ENDOSCOPY – COLD BIOPSY FORCEPS, GASTROINTESTINAL ENDOSCOPY - EXTRACTION FORCEPS - SINGLE-USE, GASTROINTESTINAL ENDOSCOPY DEVICES – ACCESSORIES – GUIDE WIRE FIXATION / VALVES, GASTROINTESTINAL ENDOSCOPY DEVICES – OTHERS, LITHOTRIPSY DEVICES (non-active) PAPILLOTOMES / SPHINCTEROTOMES – BILUMEN / TRILUMEN OR MORE / OTHERS, POLYPECTOMY SNARES – REVOLVING / NON-REVOLVING / OTHERS Non-sterile: GASTROINTESTINAL ENDOSCOPY, BITE BLOCKS LITHOTRIPSY DEVICES (non-active) DIGESTIVE ENDOSCOPY, RETRIEVAL DEVICES -OTHERS GASTROINTESTINAL ENDOSCOPY DEVICES -ACCESSORIES

Sterile: Design, Development, Manufacturing, Distribution of BILIARY BALLOON CATHETERS - HIGH PRESSURE, BILIARY TUBES, BRONCHOSCOPIC INSTRUMENTARY – OTHERS, DIGESTIVE ENDOSCOPY - HAEMOSTASIS CLIPS, DIGESTIVE ENDOSCOPY - MONOLUME NEEDLES, DIGESTIVE ENDOSCOPY - RETRIEVAL BALLOON DEVICES, DIGESTIVE ENDOSCOPY - - RETRIEVAL BASKET DEVICES - NON-REVOLVING / REVOLVING, DIGESTIVE ENDOSCOPY - RETRIEVAL DEVICES – OTHERS, ERCP CANNULAS - ONE-WAY - STANDARD TIP / TAPERED TIP/ OTHERS, ERCP CANNULAS - MORE WAYS - TAPERED TIP, ERCP AND SPHINCTEROTOMY DEVICES – OTHERS, GASTROINTESTINAL DEVICES – OTHERS, GASTROINTESTINAL ENDOSCOPY – COLD BIOPSY FORCEPS, GASTROINTESTINAL ENDOSCOPY - EXTRACTION FORCEPS - SINGLE-USE, GASTROINTESTINAL ENDOSCOPY DEVICES – ACCESSORIES – GUIDE WIRE FIXATION / VALVES, GASTROINTESTINAL ENDOSCOPY DEVICES – OTHERS, LITHOTRIPSY DEVICES (non-active) PAPILLOTOMES / SPHINCTEROTOMES – BILUMEN / TRILUMEN OR MORE / OTHERS, POLYPECTOMY SNARES – REVOLVING / NON-REVOLVING / OTHERS Non-sterile: Design, Development, Manufacturing, Distribution of GASTROINTESTINAL ENDOSCOPY, BITE BLOCKS LITHOTRIPSY DEVICES (non-active) DIGESTIVE ENDOSCOPY, RETRIEVAL DEVICES -OTHERS GASTROINTESTINAL ENDOSCOPY DEVICES -ACCESSORIES