EC Certificate - Full Quality Assurance System
Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4Supplementary Information to CE 735275
IssuedTo:No.
Issued To:

Research Instruments Limited
CE 735275
Bickland Industrial ParkResearchInstruments Limited
Falmouth
BicklandIndustrial
Park
CornwallTR11 4TA
Falmouth
United Kingdom
CornwallTR11 4TA
United Kingdom

In respect of:

Design, manufacture and final inspection of Integra micromanipulation system, Saturn laser
systems, electrically heated plates and temperature control units for use in RI Witness
systems, and sterile single-use plastic pipettes (EZ-Range) for use in Assisted Reproductive
Techniques (ART).

on the basis of our examination of the quality assurance system under the requirements of Council Directive
93/42/EEC, Annex II excluding section 4. The quality assurance system meets the requirements of the directive. For
the placing on the market of class III products an Annex II section 4 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: 2021-04-01
First Issued: 2021-04-01

Date: 2021-04-01
Date: 2021-04-01

Expiry Date: 2024-05-26
Expiry Date: 2024-05-26

Page 1 of 2
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 - Full Quality Assurance System
Supplementary Information to CE 735275
Issued To:

NumberResearch Instruments Limited
Bickland Industrial Park
FalmouthCornwallTR11 4TA
United Kingdom

Device Name

Intended purpose per IFU

MD 1110

RI Integra Micromanipulator---

MD 1110

RI Saturn Laser System---

MD 1110

RI Witness Embryology HeatedPlate---MD 0109

RI EZ-Range (RI EZ-Tip, RI EZStrip, RI EZ-Squeeze) sterile
single-use plastic pipettes---Class IIa

First Issued: 2021-04-01

Date: 2021-04-01

Expiry Date: 2024-05-26

Page 2 of 2
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 - Full Quality Assurance System
Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4

List of Significant Subcontractors
Recognised as being involved in services relating to the product covered by:Certificate No:

CE 735275

Date:2021-04-01

Issued To:

Research Instruments Limited
Bickland Industrial Park
FalmouthCornwall
TR11 4TA
United Kingdom

Subcontractor:

Service(s) supplied

CooperSurgical Distribution B.V
Celsiusweg 355928 PR Venlo
The Netherlands

EU Representative

Europlaz Technologies Ltd
The Maltings Industrial Estate
Hall Road
Southminster
CM0 7EQUKAssembly

FISBA AG
Rorschacher Strasse 268
9016 St. Gallen
Switzerland

Crucial Supplier

Swann-Morton (Services) Limited
Owlerton Green
Sheffield
S6 2BJ
United Kingdom

Radiation (Gamma Sterilization)

Page 1 of 2
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 - Full Quality Assurance System
Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4

List of Significant Subcontractors
Recognised as being involved in services relating to the product covered by:
Certificate No:

CE 735275

Date:

2021-04-01

Issued To:

Research Instruments Limited
Bickland Industrial Park
FalmouthCornwall
TR11 4TA
United Kingdom

Subcontractor:

Service(s) supplied

Transluminal SARL
65 Boulevard de la Moselle
Pompey54340
FranceManufacture

Page 2 of 2
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 - Full Quality Assurance System
Certificate History
Certificate No:

CE 735275

Date:

2021-04-01

Issued To:

Research Instruments Limited
Bickland Industrial Park
FalmouthCornwall
TR11 4TA
United Kingdom

Date
Current

ReferenceNumber3279829

ActionFirst Issue.
Transfer from SGS (NB 1639).

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.