CE DECLARATION OF CONFORMITY According to the Annex IX of the Directive 93/42/EEC
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1 CE DECLARATON OF CONFORMTY According to the Annex X of the Directive 93/42/EEC The undersigned FOR.ME.SA. SRL, manufacturer of following Medical Devices, with location in Via Don Minzoni 52/A, Noceto (PR) DECLARES Under ou responsibility that the followint Devides satisfy Essential Requirements required from Annex Directive 93/42/EEC: Description Code CLASS CND GMDN RDM Nasal aspirator FOR V /R Foam biadhesive strip for fixing the external male FOR U /R catheters (for children) 57431/R (one side ribbed in polybag Deluxe) (two side ribbed in polybag Deluxe) /R /R Hot water bottle (one side ribbed in polybag Conventional) (two side ribbed in polybag Conventional) /R /R (with cover) (oval) (cervical) 19907/R 19913/R (diam. 20 round) (diam. 25 round) (diam. 28 round) 19903/R 44199/R 44203/R (TEAM blue meas. 25 in case) /S (TEAM blue meas. 25 in polybag) /R /R ce bag (TEAM blue meas. 28 in case) /S (TEAM blue meas. 28 in polybag) /R /R (TEAM blue meas. 31 in case) /S (TEAM blue meas. 31 in polybag) /R /R (AVANA meas. 25 in case) /S (AVANA meas. 25 in polybag) 19947/R (AVANA mis. 28 in astuccio) /S (AVANA mis.28 in sacchetto) 44171/R
2 (AVANA mis. 31 in astuccio) /S (AVANA mis.31 in sacchetto) FOR (fabric cuff with velcro and ring) FOR (with velcro and ring) 44176/R 58453/R 70613/R Fabric cuff for sphygmomanometer FOR (inflatable cuff with velcro and ring 1 way) FOR (inflatable cuff with velcro and ring 2 ways) 70627/R 71494/R FOR (inflatable cuff for obese people with velcro and ring 1 way) FOR (inflatable cuff for obese people with velcro and ring 2 ways) FOR (adult 1 way) FOR (adult 2 ways) 71518/R 71520/R 58395/R 72554/R Spare parts for sphygmomanometer FOR (pediatric 1 way) FOR (pediatric 2 ways) 72560/R 72564/R FOR (obese people 1 way) FOR (obese people 2 ways) 72585/R 72591/ Anal cannula FOR U /R Vaginal cannula FOR U /R External latex catheters in polybag External siliconeee catheters nvalid ring CONVENTONAL nvalid ring with inflator inserted (DELUXE) with pump nvalid ring TEAM (DELUXE) without pump Polyurethane foam pad Soft cervical collar Rigid cervical collar FOR (diam. 25 mm) FOR (diam. 30 mm) FOE (diam. 35 mm) FOR.007.S25 (diam. 25 mm) FOR.007.S30 (diam. 30 mm) FOE.007.S35 (diam. 35 mm) (diam. 35 cm) (diam. 40 cm) (diam. 43 cm) (diam. 45 cm) P (diam.35 cm) P (diam 40 cm) P (diam 43 cm) P (diam. 45 cm) (diam. 35 cm) (diam. 40 cm) (diam. 43 cm) (diam. 45 cm) (operhorse shoe) (round) (meas. small) (meas. medium) (meas. large) (meas. extra large) (meas. small) Deluxe (meas. medium) Deluxe (meas. large) Deluxe (meas. extra large) Deluxe (meas. small) (meas. medium) 29559/R 38009/R 38014/R /R /R /R 19960/R 44231/R 44289/R 44328/R /R /R /R /R /R /R /R /R /R /R 36612/R 57562/R 57574/R 57584/R /R /R /R /R 36949/R 57600/R
3 (meas. large) (meas. extra large) 57603/R 57613/R Semirigid cervical collar Cervical collar Philadelphia (meas. small) Deluxe (meas. medium) Deluxe (meas. large) Deluxe (meas. extra large) Deluxe (meas. small) (meas. medium) (meas. large) (meas. extra large) (meas. small) (meas. medium) (meas. large) (meas. extra large) /R /R /R /R /R /R /R /R Enema irrigator FOR U V2W5DF/R Hotcold gel FOR (14x18 cm pack TNT) FOR /A (14x18 cm pack TNT in case) VHP1BU/R VHP1BG/R FOR (14x24 cm with velcro) FOR /A (14x24 cm with velcro in case) VJ41RZ/R VJK1HN/R FOR /0 (meas. 6.0) FOR /5 (meas. 6.5) V4XY2U/R V4XY36/R FOR /0 (meas. 7.0) V4XY3L/R Cotton gloves for skin FOR /5 (meas. 7.5) V4XY3Y/R allergies FOR /0 (meas. 8.0) V4XY4B/R FOR /5 (meas. 8.5) FOR /0 (meas. 9.0) V4XY4D/R V4XY4S/R Shoulder immobilizer (meas. small) (meas. medium) (meas. large) /R /R /R Cotton sheet with rings FOR (misura 50x70 cm) FOR (misura 90x140 cm) FOR (misura 130x140 cm) FOR (misura 200x140 cm) FOR (misura 230x140 cm) /R /R /R /R /R Cotton sheet with elastics FOR (misura 50x70 cm) FOR (misura 90x140 cm) FOR (misura 130x140 cm) FOR (misura 200x140 cm) FOR (misura 230x140 cm) /R /R /R /R /R FOR (misura 60x90 cm) FOR (misura 90x70 cm) FOR (misura 90x90 cm) 20002/R 57478/R 57490/R Rubber sheet with rings FOR (misura 90x100 cm) 57498/R FOR (misura 90x120 cm) 57522/R FOR (misura 90x150 cm) FOR (misura 90x180 cm) FOR (misura 90x200 cm) 57530/R 57466/R 57474/R Gel face mask FOR V /R Gel eyes mask FOR V /R White plastic mask for adults in case Silicone mask for resuscitator FOR R /R (misura 00) (misura 0) 64910/R 94799/R
4 Air cushion mask (misura 1) (misura 2) (misura 3) (misura 4) (misura 5) (neonatal, white) (pink, infant) (yellow, pediatric) (green, child) (red, small adult) (blue, adult) 64802/R 64804/R 64807/R 64808/R 64809/R /R /R /R /R /R /R Bed pan FOR Y /R Silicone resuscitator Finger cot (adult with accessories) (pediatric with accessories) (infant with accessories) (adult without accessories) (pediatric without accessories) (infant without accessories) (meas. small) (meas. medium) (meas. large) Y Y Y /R 57773/R 57780/R 76556/R 76570/R 76598/R /R /R /R Finger extension splint Y /R Frog splint Y /R Pump for invalid ring V /r Pill box FOR.TGYH.012 Pill box FOR.TGYH.007 Pill box 7 case small FOR.TGYH.AJ07 Pill box 7 case big FOR.TGYH. 098 Pill box 28 case FOR.TGYH Daily Pill Box FOR.TGYH.031 Pill box rounded 7 case (without case meas. small) (without case meas. medium) (without case meas. large) (without case meas. extra large) /R /R /R /R /R /R 37968/R 57680/R 57762/R 57763/R Pouch arm sling cotton fabric with pulling and rings (with case meas. small) (with case meas. medium) (with case meas. large) (with case meas. extra large) /R /R /R /R Reservoir bag Cast shoe (without case meas. small) (without case meas. medium) (without case meas. large) (without case meas. extra large) (with valve for adult) (with valve pediatric) (with valve infant) (without valve adult) (without valve pediatric) (without valve infant) /R /R /R /R 44537/R 64884/R 64888/R 76909/R 76927/R 76952/R /R /R /R
5 Enema spare set of 3 pieces Rubber inflation bulb Finger splint Pill cutter / /R /R /R /R /R /R /R /R /R /R /R /R /R /R /R /R FOR U /R FOR (with final valve and air manual opening valve) FOR (with final valve) (simple splint) (finger extension splint) (frog splint) S (frog splint SMALL) M (frog splint MEDUM) L (frog splint LARGE) FOR.TGYH.002 Pill cutter FOR.TGYH.005 Pill cutter /R 58352/R 58077/R 77068/R 77072/R /R /R /R /R /R Pill crusher & cutter FOR.TGYH.LMY /R Ankle binder (meas. small) (meas. medium) (meas. large) Y Y Y /R /R /R Tube for enema irrigator FOR U /R Tube for oxygen for PVC resuscitator in case /R PVC tube in case FOR (100 cm) FOR (150 cm) FOR (200 cm) R R R /R /R /R Polyethylene female urinal FOR (in polybag) Y /R FOR (in case) Y /R Polyethylene male urinal Onoff valve for silicone rianimator FOR (in polybag) FOR /T (with cap in polybag) FOR (in case) A A A /R /R /R /R
6 For this purpose FOR.ME.SA. srl guarantees and declarer under his own responsibility as follows: 1. The Device shown on this document fulfil the regulatory essential requires to Annex Directive 93/42/EEC; 2. The Device shown on this dcoument belong to the Class ; 3. The Device shown on this document AREN T MEASURNG NSTRUMENTS; 4. The Device shown on this document AREN T NTENDED FOR CLNCAL NVESTGATONS; 5. The Device shown on this document are readed in NOT STERLE package. salso declare that company FOR.ME.SA. srl will keep at the disposal of Health Authorities documentation referred to Annex V of Directive 93/42/EEC for five years (or over the whole lifetime of Device) starting last production date of Device. 2016, 14th november Place and date of issue Signature and Company s Stamp
//
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