ISO/CE Certificates

Certificate GB9617943.00
The management system of
Femcare-Nikomed Limited
Stuart Court, Spursholt Place, Salisbury Road,
Romsey, Hampshire, S051 6DJ, UK
has been assessed and certified as meefing the requirements of
Iso 13485:2003
EN ISO 13485:2012
For the following activities
Design, manufacture, servicing and distribution of:
Sterile implantable clips for female sterilisation
Sterile single use and non sterile reusable female sterilisation clip
applicators and female sterilisation applicator kits
Sterile hormone replacement trays and sterile trocar cannula
obturators for hormone replacement therapy
Devices for gynaecological, urological, orthopaedic
and general surgical procedures,
Sterile femoral sponge
Sterile suprapubic catheter introducer and kits
Sterile single use and non sterile reusable trocar cannula
Sterile replacement cannula seals
Non sterile non scalpel vasectomy kit
Distribution of medical and surgical products.
This certificate is valid from 05 January 2016 until 21 November 2018
and remains valid subject to satisfactory surveillance audits.
Re certification audit due before 21 November 2018
Issue 21. Certified since 23 August 1996
Authorised by
UKAS
MANAGEMENT
ss
SGS United Kingdom Ltd Systems & Services Certification
Rossmore Business Park Ellesmere Port Cheshire CH65 3EN UK
+44 (0)151 350-6666 f +44 (0)151 350-6600 ~.sgs.com
SGS13485-2 1114
Page 1 of 1
SG~
This document Is issued by the Company su*ct to its General Conditions of
Certification Services accessibte at wgs.cumitecms_asd_cundfttons.hbr,.
Attention is drawn to the tmitaitons of liability, thdemnl~atlog and jurisdictional
issues estabflslwd therein The withenitcity &thls document may be verified at
hUpifww~.ags.cun~lmnIOur-CompanyICertifled-Client-Dbeciodes/Certifled-Client
Directories.asp~ Any unauttarrized alteration, forgery or falafication of the
omtent or appearance of this document is unlawful and offenders may be
prosecuted to the fliltest extent of the law
EC Certificate Full Quality Assurance System: Certificate GB9617942.00
The management system of
Femcare-Nikomed Limited
Stuart Court, Spursholt Place, Salisbury Road, Romsey,
Hampshire, S051 6DJ, UK
has been assessed and certified as meeting the requirements of
Directive 931421EEC
on medical devices, Annex II (excluding Section 4)
For the following products
Sterile Filshie Sterishot system and single use disposable applicator
for permanent female contraception
Sterile Filshie Clips for permanent female sterilization
Sterile hormone replacement trays
Sterile trocar cannula obturators for hormone replacement therapy
Fempac sterile femoral sponge
Add-a-Cath sterile suprapubic catheter introducer and Add-A-Cath kits
Sterile single use trocar cannula
Sterile replacement trocar cannula seals.
Where the above scope includes class Ill medical device(s), a valid EC Design Examination
Certificate according to Annex II (Section 4) is a mandatory requirement for each device in
addition to this certificate to place that device on the market.
This certificate is valid from 15 April 2016 until 21 November 2020
and remains valid subject to satisfactory surveillance audits.
~Re certification audit due before 21 November 2018
Issue 22. Certified since 23 August 1996
‘~
Certification is based on reports numbered GB/PC 05202
Authonsed by
SGS United Kingdom
Ltd, Notified Body 0120
202B Wo~e Parkway, Weston-super-Mare, BS22 6WA UK
+44 (0)1934 522917 f +44 (0)1934 522137 www.sgs.com
SGS CE 020215
Page 1 of I
~~Thii document is Issued by the Company s. t~ ha General
• a of
Certificádon Se
aocessthle at~~gs.coeims_aXcundiUonsJrbmsr
Attention ladrawn thelknltationsoftabltity •emnlficatlon and]
issues established therein. The authentedly of this
may be reuSed at
httpJF~.ags.cuni(eniOur
-C
rttfied-Cllen Dhectodas.aapx.Myunauthoitoedalteca ,tage orfalsthcatlonoftlue
content o appearansu of this document Is unlawiol and
may be
prosecuted to the fullest mutest of the law
rr~t~’
EC Design Examination Certificate: Certificate GB9817945
Femcare-Nikomed Limited
Stuart Court, Spursholt Place, Salisbury Road, Romsey,
Hampshire, S051 6DJ, UK
Device Identification:
FilshieTM Tubal Ligation System
Intended Purpose of Device:
Sterile contraceptive tubal occlusion devices for permanent female
sterilization by occlusion of the Fallopian tubes
has been assessed and certified as meeting the requirements of
Directive 931421EEC
on Medical Devices Annex II, section 4
It is certified that the manufacturer’s design dossier (and product, where applicable) for the above device
has been examined and, based on the evidence submitted, it is considered that the device
conforms to the relevant Essential Requirements of EC Directive 93/42/EEC.
This certificate is issued in conjunction with a certificate covering the full quality assurance system to
Annex II, which must be subject to satisfactory surveillance audits.
This certificate is valid from 19 May 2014 until 07 July 2018
Issue 9
Certification is based on report number(s) GB/PC 201988 dated 30 September 2013
Addendum Date
11 February 2014
Change of sterile packaging configuration to include a pack
containing a single Fllshie Clip
Authorised by
SGS United Kingdom Limited, Notified Body 0120
202B Worle Parkway, Weston-super-Mare, BS22 6WA, UK
+44(0)1934 522917 f +44(0)1934 522137 www.sgs.com
SGSECO1 0311
Page 1 of 1
~
.1-—..—