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Organismo Notificato 0373Notified Body 0373

Istituto Superiore di Senitù

Certificaton°Certificate no. QPZ-1899-17

Addendum n?addendum no.

Data prima emissioneFirst issue dateData di emissione correnteCurrent issue dateData di scadenzaExpiry date

14.12.2017

14.12.2017

13.12.2022

03-17

GARANZIA DELLA QUALITA'DELLA PRODUZIONEsecondo l'Allegato V della Direttiva Europea 93/42/CEE esuccessive modifiche ed integrazioni(recepita in Italia con il D.Lgs. n. 46 del 24.02.1997 esuccessive modifiche ed integrazioni)

PRODUCTION QUALITYASSURANCE

according to Annex V of EC Directive 93/42/EECand subsequent modifications and integrations

(transposed in Italy by the D.Lgs. n. 46 issued on24.02./997 and subsequent modifications and integrations)

L'Istituto Superiore di Sanità,Organismo Notificato 0373, certifica cheil sistema di garanzia della qualità dellaproduzioneattuato da

The Istituto Superiore di Sanità,Notified Body 0373, certifies thattheproduction quality assurance

enforced by

Delta Med S.p.A.

Sede Legale! Registered Office:Via Guido Rossa,20 - 46019 Viadana (MN) ITALIA

per il dispositivo/i far the devicets)(vedi allegato tecnico/ see technical sheet)"

è conforme ai requisiti applicabili dellaDirettiva Europea 93/42/CEE e successivemodifiche ed integrazioni.

is in compliance with the applicablerequirements ofCouncil Directive 93/42/EEC and

subsequent modifications and integrations.

* L'allegato tecnico è parte integrante dd presente CertificatoIhe technical sheet is un integralpart f?f this Certificate.

Istituto Superiore di Sanità - viale Regina Elena, 299 - 00161Roma Italy - teL/ fax. +390649902108- www.iss.itJ\10D-"32-07-06 Certificato QPZ rev.O I del !3.02.20 17 I di 2J

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Organismo Notificato 0373Notified Body 0373

Istituto Supetiote di Saait«

ALLEGATO TECNICO TECHNICAL SHEETIlCertificaton?TheCertificateno. QPZ-1899-17 Addendum n°

addendum no. 03-17

di cui il presente allegato tecnico è parteintegrante, è da considerarsi riferito soloal/ai seguente/i prodotto/i soggetto/i asorveglianza:

of which this technical sheet is an integraipart, refers only to the following product(s)that are subject lo surveillance:

Classe (Class): IlaNome prodotto Codice(Product name) (Code)

Klinij_ect 14G 45mm/S 3175616Kliniject 16G 45mm/S 3165616Kliniject 17G 45mm/S 3155616Kliniject 18G 32mm/S 3185616Kliniject 18G 45mm/S 3145616Klinij_ect20G 32mm/S 3135616Kliniject 22G 25mm/S 3125616Kliniject 24G 19mm/S 3115616Kliniject 26G 19mm/S 3105616Kliniject V 14G 45mm/S 3170716Kliniject V 16G 45mm/S 3160716Kliniject V 17G 45mm/S 3150716Kliniject V 18G 32mm/S 3080716Kliniject V 18G 45mm/S 3140716Kliniject V 20G 32mm/S 3130716Kliniject V 22G 25mm/S 3120716Kliniject V 24G 19mm/S 3110716Kliniject V 26G 19mm/S 3102716

_._--.--_

Istituto Superiore di Sanità viale Regina Elena, 299 - 00161Roma Italy - tel./fax. +390649902108 - www.iss.it

\10D-3J2-07-()(jCerti!ìcatoQPZrc\.OI dci 13.02.:2017 1':1'" [(ic!iB

1!·SS!·"\'\\"\801Z066t906f+·X1lJ/"Pl·~11l1I1lWOll19100

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Organismo Notificato 0373Notified Bo(~y0373

Istituto Superiore di Sanits

ALLEGATO TECNICO TECHNICAL SHEET

Il Certificato n°TheCertificateno. QPZ-1899-17 Addendum n°

addendumno. 03-17

di cui il presente allegato tecnico è parteintegrante, è da considerarsi riferito soloal/ai seguente/i prodotto/i soggetto/i asorveglianza:

of which this technical sheet is an integralpart, refers only to the following product(s)that are subject lo surveillance:

Classe (Class): IlaNome prodotto Codice(Product name) (Code)

Ott.Medi-Cath P.24G 3011331OttoKliniject 14G 3075616OttoKliniject 16G 3065616OttoKliniject 17G 3055616

OttoKliniject 18G 32mm 3085616OttoKliniject 18G 45mm 3045616

OttoKliniject 20G/S 3035616OttoKliniject 22G/S 3125616OttoKliniject 24G 3015616OttoKliniject V 14G 3070716OttoKliniject V 16G 3060716OttoKliniject V 17G/S 3050716

OttoKliniject V 18G 32mm 3080716OttoKliniject V 18G 45mm 3040716

OttoKliniject V 20G 3030716OttoKliniject V 22G 3020716OttoKliniject V 24G 3010716

Istituto Superioredi Sanità vialeRegina Elena, 299- 00161Roma Italy - tel./fax. +390649902108- www.iss.it

'10D-~32-07-()(, Certificato QP/ rcv.Ot dcI13.02.2017 1':lg. 21 di 2J

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