91³Ô¹ÏÍøAccreditations & Certificates Download
The indicated certificates are available to download in Adobe Acrobat (pdf) file format. All divisions Current Quality System Third Party Accreditations :
91³Ô¹ÏÍøLimited
BSI Certificate of Registration ISO 13485:2016
Scope of Registration: The design and manufacture of surgical blades, disposable scalpels, handles and blade removers.
BSI Certificate of Registration MDSAP
Certificate number MDSAP 674417
Statement of Conformity: 91³Ô¹ÏÍøLimited is accredited to ISO 13485, the International Standard for Quality Management Systems for medical device companies. As well as this 91³Ô¹ÏÍøLimited is accredited to MDSAP (Medical Device Single Audit Programme) demonstrating that the company has been audited and conforms with, as well as ISO 13485:2016, Australia – Therapeutic Goods (Medical Devices) Regulations, 2002, Schedule 3 Part 1 (excluding Part 1.6) – Full Quality Assurance Procedure, Therapeutic Goods (Medical Devices) Regulations 2002, Schedule 3 Part 4 – Production Quality Assurance Procedure; Brazil – RDC ANVISA n.16/2013, RDC ANVISA n.23/2012, RDC ANVISA n.67/2009; Canada Medical Device Regulations – Part 1 – SOR 98/282; Japan – MHLW Ministerial Ordinance 169, Article 4 to 68, PMD Act; and USA – 21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807 – Subparts A to D
EC – Certificate (MDR – Medical Device Regulation)
Regulation (EU) 2017/745 Annex IX Chapter I and III Certificate number MDR 721051 R000 in accordance with the associated device schedule including:
Single use Surgical Surgical Scalpels and Blades – Class IIa
Sterile Suture Remover – Class Is
Reusable instruments ’Orthopaedic Instruments’ – Class Ir
UKCA Certificate - Part II of The Medical Device Regulations 2002, Annex II excluding Section 4 [as modified by Part 2 of Schedule 2A to The Medical Device Regulations 2002]
Certificate number UKCA 753776
Single use Surgical Scalpels and Blades – Class IIa
- The design and manufacture of sterile and non-sterile stainless and carbon steel surgical blades, scalpels and skin graft blades.
Sterile Suture Remover – Class Is
- Those aspects of Annex II concerned with securing and maintaining the sterile condition of sterile suture removers.
FDA: Registration Details:
Registration Number: 9611194 Operator Number: 9003320
Product Standards:
BS EN 27740:1992 / ISO 7740:1985 - Instruments for surgery, scalpels with detachable blades, fitting dimensions
BS 2982:1992 - Specification for Materials and packaging of Surgical Scalpels with detachable blades
91³Ô¹ÏÍø(Services) Limited
BSI Certificate of Registration ISO 13485:2016
Scope: The irradiation of medical equipment and ancillary products such as surgical blades, implants and clean room clothing in accordance with EN ISO 11137-1:2015.
FDA: Registration Details:
Registration Number: 3008812251 Operator Number: 9003320
91³Ô¹ÏÍø(Microbiological Laboratory Services) Limited
BSI Certificate of Registration ISO 13485:2016 Certificate number MD 75864
Scope: The provision of a service for sub-contract microbiological analysis of medical devices, their accessories and the related work environment.
UKAS Certificate of Accreditation ISO/IEC 17025:2017
Testing Laboratory No. 21371 is accredited in accordance with International Standard ISO/IEC 17025:2017– General Requirements for the competence of testing and calibration laboratories.
All divisions
Current Environmental Management System Third Party Accreditation's :
W.R. Swann Group
(Consisting of: 91³Ô¹ÏÍøLimited; 91³Ô¹ÏÍø(Services) Limited; 91³Ô¹ÏÍø(Microbiological Laboratory Services) Limited and Jewel Blade Limited)
BSI Certificate of Registration ISO 14001:2015 Certificate number EMS633531
Scope: 'The design and manufacture of surgical, craft and industrial blades & handles. The irradiation of medical equipment and ancillary products and the microbiological analysis of medical devices, their accessories and the environment.'
Current Energy Management System Third Party Accreditation's :
W.R. Swann Group
BSI Certificate of Registration ISO 50001:2018 Certificate number ENMS633525
Scope: 'The design and manufacture of surgical, craft and industrial blades and handles, including company transportation. The irradiation of medical equipment and ancillary products and the microbiological analysis of medical devices, their accessories and the environment. Principal energy uses are electricity for heating, lighting, cooling, process equipment and compressed air; natural gas for heating; hydrogen for hardening and tempering; and fuel for transportation.'
