DNV BUSINESS ASSURANCE

EC CERTIFICATE - FULL QUALITY ASSURANCE SYSTEM

Certificate No. 43219-2008-CE-NOR Rev 13.0

This Certificate consists of 4 pages

This is to certify that the Quality Management System of

Zerone Co., Ltd.

(Shinil IT UTO Bldg., Dangjeong-dong) #810, LS-ro 13, Gunpo-si, Gyeonggi-do, Korea
for design, production and final product inspection/testing of
Electrosurgical and Ultrasonic Surgical Unit
Laparoscopy Trocar, Infusion Pump,
Syringe pump, Suction-Irrigation Pump
has been assessed with respect to
the conformity assessment procedure described in Article 11.3.a and Annex II excluding section 4
(Module H) of Council Directive 93/42/EEC on Medical Devices, as amended, and found to comply

Further details are given overleaf

Place and date: This Certificate is valid until:
Høvik, 23 November 2016 17 July 2021

For DNV GL BUSINESS ASSURANCE

NORWAY AS

Tone Kolpus Notified Body No.: Sholeh Gheissar

Certification Manager 0434 Technical Reviewer

This Certificate has been digitally signed. See www.dnv.com/digitalsignatures for more info

Notice: The certificate is subject to terms and conditions overleaf. Any significant changes in design or construction may render this certificate invalid.
If any person suffers loss or damage which is proved to have been caused by any negligent act or omission of Det Norske Veritas, then Det Norske Veritas shall pay compensation to such person for his proved direct loss or damage. However, the compensation
shall not exceed an amount equal to ten times the fee charged for the service in question, provided that the maximum compensation shall never exceed USD 300.000. In this provision “Det Norske Veritas” shall mean the Foundation Det Norske Veritas as well as
all its subsidiaries, directors, officers, employees, agents and any other acting on behalf of Det Norske Veritas.

Det Norske Veritas AS, Veritasveien 1, 1322 Høvik, Norway. Tel: +47 67 57 9900 Fax: +47 6757 9911 www.dnv.com
Page 1 of 4
 Cert. No.: 43219-2008-CE-NOR
Rev. No.: 13.0
Project No.: PRJC-40529-2007-PRC-KOR

Jurisdiction
Application of Council Directive 93/42/EEC of 14 June 1993, adopted as ‘Forskrift for Medisinsk
Utstyr’ by the Norwegian Ministry of Health and Care Services.

Certificate history
Revision Description Issue Date
Original certificate (former 2006-OSL-MDD-0272) 2006-07-17
1.0 Extension of scope – new product added 2008-12-23
2.0 Extension of scope – new model added 2009-11-24
3.0 Extension of scope – new model added 2010-04-21
4.0 Extension of scope – new model added 2011-01-04
5.0 Recertification 2011-07-17
6.0 Change of address of manufacturer 2012-07-05
7.0 Scope added (Laparoscopy Trocar) 2013-06-13
8.0 Scope added ( Infusion pump) 2014-02-13
9.0 Model added ( SENS-Z, ZTC-10,ZTC-30,ZTC-40) 2014-06-12
10.0 Model added ( ACE Series ) 2014-10-30
11.0 Model added ( bold font ) 2015-11-11
12.0 Recertification and scope extension (Suction-Irrigation Pump) 2016-10-05
13.0 EU Representative changed (Bold) 2016-11-23

Products covered by this Certificate

Product Description Product Class
Electrosurgical Unit  ZEUS VISION IIb
 ARGON-Z
 ZEUS-400
 ZEUS-300
 ZEUS-200S
 ZEUS-200
 ZEUS-150
 ZEUS-100
 ZEUS-80
 ZERO50
 SENS-Z
 DOCTANZ TOUCH
 DOCTANZ400
Det Norske Veritas AS, Veritasveien 1, 1322 Høvik, Norway. Tel: +47 67 57 9900 Fax: +47 6757 9911 www.dnv.com
Page 2 of 4
 Cert. No.: 43219-2008-CE-NOR
Rev. No.: 13.0
Project No.: PRJC-40529-2007-PRC-KOR

 DOCTANZ300
 DOCTANZ200S
 DOCTANZ200
 DOCTANZ150
 DOCTANZ100
 DOCTANZ80
 ACE VISION
 ACE-400
 ACE-300
 ACE-200S
 ACE-200
 ACE-150
 ACE-100
 ACE-80
Ultrasonic Surgical Unit  ULTRA-Z IIb
Laparoscopy Trocar  ZT-10, ZT-12F, ZT-20, ZT-22F, ZT-30, ZT-40 IIa
 ZTC-10, ZTC-30, ZTC-40,
 ZT-10T, ZT-20T, ZT-30T, ZT-40T
INFUSION PUMP  INFU-Z 1000 IIb
 INFU-Z 4000
SYRINGE PUMP  SYRIN-Z 4000 IIb
SUCTION-IRRIGATION  ZP-1000 IIa
PUMP

The complete list of devices is filed with the Notified Body.

Sites covered by this certificate

(Shinil IT UTO Bldg., Dangjeong-dong) #810, LS-ro 13, Gunpo-si, Gyeonggi-do, Korea

EU Representative

CMC MEDICAL DEVICES & DRUGS S.L. C/Horacio Lengo N° 18, CP 29006, Málaga, Spain

Det Norske Veritas AS, Veritasveien 1, 1322 Høvik, Norway. Tel: +47 67 57 9900 Fax: +47 6757 9911 www.dnv.com
Page 3 of 4
 Cert. No.: 43219-2008-CE-NOR
Rev. No.: 13.0
Project No.: PRJC-40529-2007-PRC-KOR

Terms and conditions

The certificate is subject to the following terms and conditions:
• Any producer (see 2001/95/EC for a precise definition) is liable for damage caused by a defect in his product(s), in
accordance with directive 85/374/EEC, as amended, concerning liability of defective products.
• The certificate is only valid for the products and/or manufacturing premises listed above.
• The Manufacturer shall fulfil the obligations arising out of the quality system as approved and uphold it so that it
remains adequate and efficient.
• The Manufacturer shall inform the local DNV Office of any intended updating of the quality system and DNV will
assess the changes and decide if the certificate remains valid.
• Periodical audits will be held, in order to verify that the Manufacturer maintains and applies the quality system DNV
reserves the right, on a spot basis or based on suspicion, to pay unannounced visits.

The following may render this Certificate invalid:

• Changes in the quality system affecting production.
• Periodical audits not held within the allowed time window.

Conformity declaration and marking of product

When meeting with the terms and conditions above, the producer may draw up an EC declaration of conformity and legally
affix the CE mark followed by the Notified Body identification number of DNV.

END OF CERTIFICATE

Det Norske Veritas AS, Veritasveien 1, 1322 Høvik, Norway. Tel: +47 67 57 9900 Fax: +47 6757 9911 www.dnv.com
Page 4 of 4