EC Certificate - Production Quality Assurance

Directive 93/42/EEC on Medical Devices, Annex V

Supplementary Information to CE 672491

Issued
No. To: Nilymed Ltd
CE 672491
Hatzoref 6
Issued To: Nilymed Ltd
Migdal Haemek
Hatzoref
Israel6
Migdal Haemek
Israel

In respect of:

Those aspects of Annex V related to securing and maintaining sterility in the manufacture of
disposable, single use, sterile covers and surgical aids for use in operating rooms such as
video camera covers, X-Ray Cassette covers, ultrasound probe covers, C-arm covers,
Microscope covers, light handle covers, UNI covers, diathermy pouches, skin markers, tip
cleaners, tube holders, needle counters, magnetic drapes, dome bags and banded bags.

on the basis of our examination of the quality assurance system under the requirements of Council Directive
93/42/EEC, Annex V. The quality assurance system meets the requirements of the directive. For the placing on the
market of class IIb and class III products an Annex III certificate is required.

For and on behalf of BSI, a Notified Body for the above Directive (Notified Body Number 2797):

Gary E Slack, Senior Vice President Medical Devices

First Issued: 2017-09-25 Date: 2019-10-10 Expiry Date: 2022-09-24

First Issued: 2017-09-25 Date: 2019-10-10 Expiry Date: 2022-09-24

Page 1 of 4

Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required
surveillance activities of the Notified Body. This approval excludes all products designed and/or manufactured by a third party on behalf of the company
named on this certificate, unless specifically agreed with BSI.
This certificate was issued electronically and is bound by the conditions of the contract.

Information and Contact: BSI, Say Building, John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands Tel: + 31 20 346 0780
BSI Group The Netherlands B.V. registered in The Netherlands under 33264284.
A member of BSI Group of Companies.
EC Certificate - Production Quality Assurance
Supplementary Information to CE 672491

Issued To: Nilymed Ltd

Hatzoref 6
Migdal Haemek
Israel

NBOG code(s) Device description Intended purpose

Class Is
MD 0100 Diathermy Pouch The sterile Diathermy pouch is used for holding the
diathermy pencil, suction tube and instruments during the
surgical procedure. It helps the surgeon organising his
medical tools for the operation. Single use, ETO sterilized.
MD 0100 Skin marker Sterile Skin marker is used to mark the area of the
operating incision by the surgeon before washing and
disinfecting the patient. Single use, ETO sterilized.
MD 0100 Light handle cover/Uni Glove Single use sterile cover and surgical aids. ETO sterilized.
cover
MD 0100 Tip cleaner Sterile Tip cleaners are used to remove coagulated blood
with tissue attached to diathermy pencils and scalpels.
Single use, ETO sterilized.

First Issued: 2017-09-25 Date: 2019-10-10 Expiry Date: 2022-09-24

Page 2 of 4

Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required
surveillance activities of the Notified Body. This approval excludes all products designed and/or manufactured by a third party on behalf of the company
named on this certificate, unless specifically agreed with BSI.
This certificate was issued electronically and is bound by the conditions of the contract.

Information and Contact: BSI, Say Building, John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands Tel: + 31 20 346 0780
BSI Group The Netherlands B.V. registered in The Netherlands under 33264284.
A member of BSI Group of Companies.
EC Certificate - Production Quality Assurance
Supplementary Information to CE 672491

Issued To: Nilymed Ltd

Hatzoref 6
Migdal Haemek
Israel

NBOG code(s) Device description Intended purpose

Class Is
MD 0100 Needle counter Sterile Needle counter is used to facilitate the process of
counting contaminated needles and sharps in the
operating room. It also prevents the operating room staff
from being cut by the contaminated needles and sharps.
Single use, ETO sterilized.
MD 0100 Magnetic Drape Sterile Magnetic drape, placed over the patient close to
incision area, is used during surgery procedure in order to
put the instruments on it and to secure them from falling
during the operation.
MD 0100 Lens Covers Single use sterile cover and surgical aids. ETO sterilized.
MD 0100 Microscope Covers Single use sterile cover and surgical aids. ETO sterilized.
MD 0100 NILY Probe covers Single use sterile cover and surgical aids. ETO sterilized.
MD 0100 NON-LATEX Probe Covers Single use sterile cover and surgical aids. ETO sterilized.

First Issued: 2017-09-25 Date: 2019-10-10 Expiry Date: 2022-09-24

Page 3 of 4

Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required
surveillance activities of the Notified Body. This approval excludes all products designed and/or manufactured by a third party on behalf of the company
named on this certificate, unless specifically agreed with BSI.
This certificate was issued electronically and is bound by the conditions of the contract.

Information and Contact: BSI, Say Building, John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands Tel: + 31 20 346 0780
BSI Group The Netherlands B.V. registered in The Netherlands under 33264284.
A member of BSI Group of Companies.
EC Certificate - Production Quality Assurance
Supplementary Information to CE 672491

Issued To: Nilymed Ltd

Hatzoref 6
Migdal Haemek
Israel

NBOG code(s) Device description Intended purpose

Class Is
MD 0100 C-Arm cover Single use sterile cover and surgical aids. ETO
sterilized.

MD 0100 Ultrasound Probe Covers Single use sterile cover and surgical aids. ETO
sterilized.

MD 0100 Video Camera Covers Single use sterile cover and surgical aids. ETO
sterilized.

MD 0100 Tube Holders Single use sterile cover and surgical aids. ETO
sterilized.
MD 0100 X-Ray Cassette Covers Single use sterile cover and surgical aids. ETO
sterilized.
MD 0100 Dome Bags Single use sterile cover and surgical aids. ETO
sterilized.
MD 0100 Banded Bags Single use sterile cover and surgical aids. ETO
sterilized.

First Issued: 2017-09-25 Date: 2019-10-10 Expiry Date: 2022-09-24

Page 4 of 4

Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required
surveillance activities of the Notified Body. This approval excludes all products designed and/or manufactured by a third party on behalf of the company
named on this certificate, unless specifically agreed with BSI.
This certificate was issued electronically and is bound by the conditions of the contract.

Information and Contact: BSI, Say Building, John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands Tel: + 31 20 346 0780
BSI Group The Netherlands B.V. registered in The Netherlands under 33264284.
A member of BSI Group of Companies.
EC Certificate - Production Quality Assurance
Directive 93/42/EEC on Medical Devices, Annex V

List of Significant Subcontractors

Recognised as being involved in services relating to the product covered by:

Certificate No: CE 672491

Date: 2019-10-10
Issued To: Nilymed Ltd
Hatzoref 6
Migdal Haemek
Israel

Subcontractor: Service(s) supplied

Mediplast Israel Ltd. ETO Sterilization
7, Ha'Yerkon str.
Yavne
Israel

MedNet GmbH EU Representative

Borkstraße 10
Münster
48163
Germany

Page 1 of 1

Information and Contact: BSI, Say Building, John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands Tel: + 31 20 346 0780
BSI Group The Netherlands B.V. registered in The Netherlands under 33264284.
A member of BSI Group of Companies.
EC Certificate - Production Quality Assurance
Certificate History
Certificate No: CE 672491
Date: 2019-10-10
Issued To: Nilymed Ltd
Hatzoref 6
Migdal Haemek
Israel

Reference
Date Action
Number
25 September 2017 8726672 First issue.
19 February 2019 8726677 Traceable to NB 0086.
Current 9754079 Removal of site at Lamdan St. Tel-Aviv.
Change of legal manufacturer’s address from 2 Lamdan St. Tel-
Aviv 69414 Israel to Hatzoref 6 Migdal Haemek Israel.
Addition of product list.

Page 1 of 1

Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required
surveillance activities of the Notified Body. This approval excludes all products designed and/or manufactured by a third party on behalf of the company
named on this certificate, unless specifically agreed with BSI.
This certificate was issued electronically and is bound by the conditions of the contract.

Information and Contact: BSI, Say Building, John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands Tel: + 31 20 346 0780
BSI Group The Netherlands B.V. registered in The Netherlands under 33264284.
A member of BSI Group of Companies.