a

5

I1

h-

h-

Q

Q

0)

tw>

^w•Ilia

•̂ilia

>3

0h-

I-

^

A

MEDICAL DEVICE SINGLE AUDFT PROGRAM I

IE

TOYSUD

America

CERTIFICATENo. QS6 020326 0061 Rev. 00

Certificate Holder: Institut Straumann AGPeter Merian-Weg 124002 BaselSWITZERLAND

Certification Mark:

TOVSUD

Scope of Certificate:

Standard(s):

Design and Development, Manufacturingand Distribution of Implants, Dental Materials,Prosthetic Components, Invasive and Non-lnvasiveInstruments, Auxiliary Components, Cassettes(Product and Product Related Services) for Use inOral and Extraoral Implantology (Maxillo- FacialSurgery) and Dental Prosthetic Restoration

ISO 13485:2016

Regulatory Authority(ies): Australia TGA, Brazil ANVISA, Health Canada,USA FDA, MHLW / PMDA.See attached for listing of specificregulatory requirements.

The Certification Body ofTUV SUD America Inc. certifies that the quality management system of themanufacturer listed above has been audited against the stated criteria and found to conform to thosecriteria for the scope of certification listed. Validity of this certificate can be obtained by visiting thewebsite https://www.tuev-sued.de/product-testing/certificates

TUV SUD America Inc. is an MDSAP Recognized Auditing Organization.

DUNS No: 48-359-9259

Effective Date:

Expiry Date:

Page 1 of 3Date of Issue: 2018-12-21

2018-12-05

2021-12-04

X/TUV SUD America Inc.

(Arie Henkin )Manager, Certification Body MHS

10 Centennial Drive Ste 207 • Peabody, MA 01960 USA • www.tuvsud.comTOY

[^-

I 55

I 6

g

d

§

0(f)

s

U)

s

g

?b !:!!111

8W•liia

•̂IIIEI

R'?•liin

§

Q=>w

Q^w

>

a

?̂>

A

MEDICAL DEVICE SINGLE AUDn- PROGRAM ITOY

SUD

America

No. QS6 020326 0061 Rev. 00

Regulatory Requirements: AudiVCertification Criteria

Facility(ies):

Page 2 of 3Date of Issue: 2018-12-21

AustraliaTherapeutic Goods (Medical Devices) Regulations 2002

- Schedule 3, Part 1

Brazil-RDCANVISAn. 16/2013-RDCANVISA n.23/2012- RDC ANVISA n. 67/2009

Canada

- Medical Device Regulations SOR/98-282, Part 1

United States- 21 CFR Part 803- 21 CFR Part 806- 21 CFR Part 807- 21 CFR Part 820-21 CFR Part 821

Japan- MHLW Ministerial Ordinance 169, Article 4 to Article 68- PMD Act

Institut Straumann AGPeter Merian-Weg 12, 4002 Basel, SWITZERLAND

Institut Straumann AGGartenstrasse 143, 4002 Basel, SWITZERLAND

Straumann Manufacturing Inc60 Minuteman Road, Andover MA 01810, USA

Straumann Villeret SALes Champs du dos 2, 2613 Villeret, SWITZERLAND

Etkon GmbHRiquetstrasse 8 & Koburger Strasse 45, 04416 Markkleeberg,GERMANY

Straumann Villeret SAGrand Rue 53 a, 2606 Corgemont, SWITZERLAND

X/(Arie Henkin)Manage)*, Certification Body MHS

TUV SOD America Inc. • 10 Centennial Drive Ste 207 • Peabody, MA 01960 USA • www.tuvsud.comTOV

,;;

S QI ^5M3

=)

b

Q=)c^>

Q

1>

Q

1^

•=)ft)b>=)

w

6h-

I?

•̂liia

•̂liia

13-?•IIIC

>1;=.h-

Q

?!a0

I-

.00w

Q=)w>

>=)

A

MEDICAL DEVICE SINGLE AUDFT PROGRAM |TOY

SUD

America

CERTIFICATENo. QS6 020326 0061 Rev. 00

Facility Scopes:

Page 3 of 3Date of Issue: 2018-12-21

Institut Straumann AGPeter Merian-Weg 12, 4002 Basel, SWITZERLAND

Certificate HolderDUNS No: 48-359-9259

Institut Straumann AGGartenstrasse 143, 4002 Basel, SWITZERLAND

Production, Warehouse Logistics, Receiving and DistributionDUNS No: 48-359-9259

Straumann Manufacturing Inc60 Minuteman Road, Andover, MA 01810, USA

Production of Implants, Prosthetic Components and Instrumentsfor Oral and Extraoral ImplantologyDUNS No: 62-264-1939

Straumann Villeret SALes Champs du dos 2, 2613 Villeret, SWITZERLAND

Production of Implants, Prosthetic Components and Instrumentsfor Oral and Extraoral ImplantologyDUNS No: 48-013-6550

Etkon GmbHRiquetstrasse 8 & Koburger Stra&e 45, 04416 Markkleeberg,GERMANY

Production and Distribution of Prosthetic Components and DentalRestorations and Dental MaterialsDUNS No: 31-332-7317

Straumann Villeret SAGrand Rue 53a, 2606 Corgemont, SWITZERLAND

Production of Implants, Prosthetic Components and Instrumentsfor Oral and Extraoral ImplantologyDUNS No: 48-013-6550

X/(ArieHenkin)Manager, Certification Body MHS

TUV SOD America Inc. • 10 Centennial Drive Ste 207 • Peabody, MA 01960 USA • www.tuvsud.comTUV