CERTIFICATE
Number: 2247783
The management system of the organization(s) and locations mentioned on the addendum belonging to:

Sarstedt AG & Co. KG
Sarstedtstraße 151588 Nümbrecht
Germany
Manufacturer Facility Identifier F004391
Conforms with the following standard and regulatory requirements:

ISO 13485:2016
Australia:
Brazil:Canada:Japan:
United States:

Therapeutic Goods (Medical Devices) Regulations, 2002 and Schedule 3 Part 1(excluding Part 1.6) - Full Quality Assurance Procedure
RDC ANVISA n. 665/2022, 551/2021 and 67/2009
Medical Devices Regulations - Part 1- SOR 98/282
MHLW Ministerial Ordinance 169, Article 4 to Article 68 and PMD Act
21 CFR 803, 21 CFR 806, 21 CFR 807 - Subparts A to D and 21 CFR 820

Scope:
Design and development, manufacture and distribution of needles, lancets, containers for venous bloodcollection, devices for ESR, devices for capillary blood collection, containers for collection of samples fromthe human body, adapters, umbilical clamps, tissue culture supplies, transport swabs, tube strippers, heatsealers, blood tube mixers, automated devices for handling blood tubes, pipettes and related accessories
Certificate expiry date:2025-07-01
Certificate effective date: 2023-07-01
Certified since:
2020-07-15
This certificate is valid for the organization(s) and/or locations mentioned on the addendum.
DEKRA Certification B.V.

jB.T.M. Holtus
Managing Director

YJ.M.A. McKenzie
Certification Manager© Integral publication of this certificate and adjoining reports is allowed
The validation of the validity of this certificate can be checked through DEKRA's website using the following link:
https:/www.dekra-product-safety.com/en/certified-organizations
DEKRA Certification B.V. is recognized under the Medical Devices Single Audit Program.

DEKRA Certification B.V. Meander 1051, 6825 MJ Arnhem P.O. Box 5185, 6802 ED Arnhem, The Netherlands
T +31 88 96 83000 F +31 88 96 83100 www.dekra.nl Company registration 09085396
Page 1 of 3

ADDENDUM
To certificate: 2247783
The management system of the organization(s) and/or location(s) of:Sarstedt AG & Co. KG
Sarstedtstraße 151588 Nümbrecht
Germany
Certified organization(s) and/or locations:Different scope
Sarstedt AG & Co. KG
Sarstedtstraße 151588 Nümbrecht
Germany
Facility Identifier F004391

Design and development, manufacture, and distribution ofcontainers for venous blood collection, devices for ESR,
containers for collection of samples from the human body, tissue
culture supplies, and related accessories.
Design and development and distribution of needles, lancets,
devices for capillary blood collection, adapters, umbilical clamps,pipettes, transport swabs, tube strippers, heat sealers, blood
tube mixers, automated devices for handling blood tubes andrelated accessories.

Sarstedt AG & Co. KG
Winterborner Straße
51588 Nümbrecht
Germany
Facility Identifier F004391Manufacture of needles, devices for capillary blood collection,adapters, sample containers for human specimens, generallaboratory products, and related accessories.

Sarstedt AG & Co. KG
Industriegelände 1651674 Wiehl
Germany
Facility Identifier F004391

Manufacture of IVD containers and related accessories

Sarstedt AG & Co. KG
Boschstraße 1553359 Rheinbach
Germany
Facility Identifier F004392

Manufacture of sample containers for human specimens,
general laboratory products, laboratory products suitable for invitro diagnostic procedures

DEKRA Certification B.V. Meander 1051, 6825 MJ Arnhem P.O. Box 5185, 6802 ED Arnhem, The Netherlands
T +31 88 96 83000 F +31 88 96 83100 www.dekra.nl Company registration 09085396
Page 2 of 3

ADDENDUM
To certificate: 2247783
The management system of the organization(s) and/or location(s) of:Sarstedt AG & Co. KG
Sarstedtstraße 151588 Nümbrecht
Germany
Sarstedt AG & Co. KG
Ernst-Stenner-Straße 1558675 Hemer
Germany
Facility Identifier F004477

Addendum expiry date:
Addendum effective date:

Manufacture of IVD containers and related accessories.

2025-07-01
2023-07-01

DEKRA Certification B.V. Meander 1051, 6825 MJ Arnhem P.O. Box 5185, 6802 ED Arnhem, The Netherlands
T +31 88 96 83000 F +31 88 96 83100 www.dekra.nl Company registration 09085396
Page 3 of 3