Certificate of Conformity
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1 Certificate of Conformity We confirm that the Technical Documentation for the below mentioned (Medical Devices of the Class I) according to the Council Directive 93/42/EEC as amended (2007/47/EC) Hospital Medical Furniture, Hospital Hollowware, OT Equipments, Medical Disposables, Medical and Surgical Rubber Goods, Diagnostic Equipments and s, Miscellaneous Surgical Medical s, Rehabilitation Aids & Orthopaedic Instruments (For Detailed Specifications, Refer to Annexure of this Certificate, Pages 07) Manufactured by Company complies with the applicable requirements of the Directive 93/42/EEC as amended (2007/47/EC). Referring to the intended use, the Certification Body has conducted with successful results the review of the Manufacturer s Technical documentation of the certified product according to above mentioned Directive and appropriate Harmonized European Standards. This Certificate is issued under the following conditions: 1. The Manufacturer s Technical Documentation, as required for Class I Devices, has been reviewed and found to comply with the requirements in Annex VII, Section It applies only to the above mentioned Medical Devices. 3. The Manufacturer is obligated to assure conformity of all the Medical Devices of the respective model to the type assessed by the mean of this Certificate. 4. Any significant changes in the Design or Process used to manufacture the, or revision to the Directives or standards referred above may require special audit by Eurotech Assessment and Certification Services Ltd. The product liability rests with the Manufacturer or his Representative in accordance with Council Directive. 5. After fulfilling the relevant EU Legislation Requirements, the Manufacturer shall affix to each Medical Device, CE Marking according to the following example: Deliberate misuse of certificate will results in cancellation without notification. To check current validity of certificate, log on to
2 Group 1 Hospital Medical Furniture Hospital Beds Delivery Beds / Gynaecological Beds Ward Furniture Stretchers Mobility Aids ICU Bed Electric/Mechanical Fowler Bed, Semi Fowler Bed General /Standard Bed, Attendant Bed, Orthopaedic Bed Paediatric Bed Infant Bed/Cot/Cribs Examination Bed/Table Delivery Bed / Gynecological Bed Group 2 Hospital Hollowware Hospital Hollowware Saline Stand Examination Lamp/ Angle Poise Lamp, Swaddling Bed/Table, Blood Donor Chair Single Fold, Double Fold, Two Fold, Three Fold, Four Fold, with wheels, without wheels, Salvage Stretchers, Spine Board Ambulance Stretcher, Stretcher Chairs, Stretcher Trolleys Wheel Chairs, Walker / Walker Rollators, Walking Sticks/Crutches, Commode Chair, Shower chair Urinals (Male & Female) Spittoons /Sputum Mugs (Stainless Steel / Plastic) Douche Cans (Stainless Steel / Plastic) Bed Pans (Stainless Steel / Plastic) Buckets (Stainless Steel / Plastic) Bowls & Basins (Stainless Steel / Plastic) Instrument Trays (Stainless Steel / Plastic) Kidney Trays (Stainless Steel / Plastic) Dressing Drums (Stainless Steel) Vomit Bag 01 of 07
3 Group 3 OT Equipments OT Tables Operation Theatre Table- Electrometric, Hydraulic, Mechanical & Electro Mechanical OT Lights Operation Theatre Light Mobile, Ceiling & Wall Mounted Group 4 Medical Disposables Umbilical Clamp Cord - Urine Bag - Tongue Depressor Disposable Wooden Disposable Non-Woven Reusable Examination Gloves - Surgical gown, Nurse gown, Scrub suit, Lab Coat, Face Mask, Cap & Apron Surgical gown, Nurse gown, Scrub suit, Lab Coat, Face Mask, Cap, Disposable PE Apron/Reusable PVC apron Examination Gloves Latex, Non Sterile, Disposable 02 of 07
4 Group 5 Medical and Surgical Rubber Goods Hot Water Bottle - Invalid Rings /Air Cushion Tourniquet Latex & Latex Free Rubber Sheeting/ Mackintosh Sheeting Breast Pump Surgical Rubber Tubing Chloroform Bellow Atomizer Bulb Ice Bag Breast Pump, Manual Surgical Rubber Tubing Large, Surgical Rubber Tubing Medium & Surgical Rubber Tubing Small Chloroform Bellow Automizer Bulb with Metal Valve Oval, Black / Ash Colour Automizer Bulb with Metal Valve & Rubber Tube black/ ash colour Atomizer Bulbs with Long tube (single bellow) in orange colour Round- Sizes available 2 Oz. (50 ml) & 4 Oz. (100 ml). Oval- Sizes available 2 Oz. (50 ml) & 4 Oz. (100 ml). Throat- Sizes available 2 Oz. (50 ml) & 4 Oz. (100 ml). 03 of 07
5 Group 6 Diagnostic Equipments and s Tuning Forks - Bung IV White - Otoscope and Ophthalmoscope Diagnostic Set Stethoscopes and Spare Parts Battery operated Otoscope (Auroscope Set) Otoscope (Pin Connection System) Battery Operated Ophthalmoscope, Battery Operated Ophthalmoscope with Otoscope, Battery Operated Diagnostic set (Pin Contacting Fitting) 2.5V Standard illumination for use with 2 batteries type Professional Otoscope, Battery operated Professional Ophthalmoscope, Battery Operated Professional Ophthalmoscope Diagnostic Series, Battery operated Otoscope Cum Ophthalmoscope Set, Battery Operated Stethoscopes Dual Headed Regular Stethoscopes Dual Headed Microfon Stethoscopes Dual Headed Regular Brass Stethoscopes Dual Headed Pediatric Brass Stethoscopes Dual Headed, Diamond Stethoscopes Dual Headed, Deluxe Stethoscopes Dual Headed, Cardio Stethoscopes Single Headed Nurse Scope Stethoscopes Foetal Stethoscopes Cardio Stethoscope Single Head for Adults Stethoscope Deluxe Single Head for Adults Sprague Rappaport Type Stethoscope Deluxe Doctor's Single Head Stethoscope Stethoscope for Adults Cardio Type Stethoscope Deluxe for Adults Stethoscope Tubes 04 of 07
6 Group 6 Diagnostic Equipments and s Armlet Bag for new born, (5.7 x 30.5cm). for 1-3 years, (7 x 30.5cm) for 3-7 years, (8.3 x 35cm) for 7-10 years, (9.5 x 38cm) for adult, (14.5 x 51.5) for obese (17.5 x 63cm) for thigh (21 x 83cm) Group 7 Miscellaneous Surgical Medical s Needle Syringe Destroyer Blanket Emergency - Group 8 Rehabilitation s & Aids Bandages Needle Syringe Destroyer Electrical & Manual W.O.W Bandages, B. P Bandage Skin Traction Orthopaedic Bandage / Padding Elastic Adhesive Bandage, B. P Cotton Crepe Bandage, B.P. Triangular Bandage Cotton Plaster of Paris Bandages, BP 05 of 07
7 Group 9 Orthopaedic Instruments Orthopaedic Instruments Instruments Set for Perfect Tibial Nails Instruments Set for Perfect Femoral Nails Instruments Set for Multi-Fix Tibial & Femoral Nails Instruments Set for Multi-Fix Tibial & Femoral Nails with Distal Jig Instruments Set for Easy Universal Nails Instruments Set for Gaam Nails Instruments set for Humeral Nails Cannulated Instruments set for Humeral Nails Unreamed Instruments Set for Tens Nails Kuntscher Nails Instruments Set Instruments for Ender Nails Instruments for Rush Nails Pins & Wire Instruments Small Fragment Instruments Set combo with standard instruments & locking instruments Small Fragment Safety Lock Instruments Set Small Fragment Instruments Set Damaged / Broken Screws Removal Instruments Set Large Fragment Instruments Set Combo with Standard Instruments & Locking instruments Large Fragment Instruments Set Instruments set for 4.0mm Cannulated Cancellous screws Instruments set for 4.5mm Cortex Cannulated screws Instruments set for 7.0mm Cancellous Cannulated screws Instruments set for 6.5mm Cancellous Cannulated screws Mini Fragment Instruments Set Bone Holding Forceps Set Instruments Set for Condylar Plate 06 of 07
8 Group 9 Orthopaedic Instruments Orthopaedic Instruments Instruments Set for Angled Blade Plate Paediatric DHS/DCS Instruments Set DHS/DCS Plate Instruments Set Instruments for Jewett Nails Plates Femoral Head Instruments Set Instruments set for Modular Bipolar and Total Hip Replacement Set Instruments for Universal External Fixator 4.0 mm Instruments for Universal External Fixator 8.0 mm Instruments for Distal Radius External Fixator Instruments for Dynamic External Fixator Instruments for the Rail Fixation System Instruments for Paediatric Rail System Instruments for Posterior Thoracolumbar Instruments for Paediatric Thoracolumbar Instruments for Minimal Invasive Screw System Instruments for Interbody Fusion Cage System Instruments for Dual Tap Self-Centering Screw System 07 of 07
Certificate of Conformity
Certificate of Conformity We confirm that the Technical Documentation for the below mentioned (Medical Devices of the Class I) according to the Council Directive 93/42/EEC as amended (2007/47/EC) Body
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