EUDAMED update: Apr 23, 2024

Cepheid AB

SE-MF-000002020

Active2 devices

Address: Röntgenvägen , 5 SE-171 54 Solna
Role: Manufacturer
Date of registration: Mar 11, 2021
Country: Sweden

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Cepheid AB is a medical device manufacturer registered in EUDAMED. The company has 2 devices on the EU market across 2 countries. Headquartered in Solna, Sweden. Explore the regulatory profile, devices and certificates on MD Atlas.

Role
Country
Date of registration
Address

EUDAMED update: Apr 23, 2024

Cepheid AB

SE-MF-000002020

Active2 devices

Address: Röntgenvägen , 5 SE-171 54 Solna
Role: Manufacturer
Date of registration: Mar 11, 2021
Country: Sweden

Is this your company? Claim it to add your logo, story and links — free.Claim this page

About Cepheid AB

SRN: SE-MF-000002020
Role: Manufacturer
Country: Sweden
Organization name: Cepheid AB
EU VAT number: SE556595618101
EORI: SE5565956181
Trade register: 556595-6181
Date of registration: Mar 11, 2021

Contact details for Cepheid AB

Phone: +46 8 684 370 00
Email: cepabprrc@cepheid.com
Website: www.cepheid.com
Address: 5, RÖNTGENVÄGEN SE-171 54 SOLNA SWEDEN

Competent authority

Name: Swedish Medical Products Agency
SRN: SE-CA-030
Phone: +46 18 17 46 00
Email: registrator@lakemedelsverket.se

Officers and regulatory representatives of Cepheid AB

KIRSEL Lena
Senior Manager of Regulatory Affairs Delegated Tasks/Duties: • The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date. • In the case of devices for performance studies intended to be used in the context of interventional clinical performance studies or other performance studies involving risks for the subjects, the statement referred to in Section 4.1 of Annex XIV is issued
Hidden
SEDLENIEKS Helena
Director Quality Systems The conformity of the device is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released. The post-market surveillance obligations are complied with in accordance with Article 10(9) The reporting obligations referred to in Article 82 to 86 are fulfilled.
Hidden

Certificate health for Cepheid AB

No certificates registered for this manufacturer.

Devices by risk class

About Cepheid AB

SRN: SE-MF-000002020
Role: Manufacturer
Country: Sweden
Organization name: Cepheid AB
EU VAT number: SE556595618101
EORI: SE5565956181
Trade register: 556595-6181
Date of registration: Mar 11, 2021

Contact details for Cepheid AB

Phone: +46 8 684 370 00
Email: cepabprrc@cepheid.com
Website: www.cepheid.com
Address: 5, RÖNTGENVÄGEN SE-171 54 SOLNA SWEDEN

Competent authority

Name: Swedish Medical Products Agency
SRN: SE-CA-030
Phone: +46 18 17 46 00
Email: registrator@lakemedelsverket.se

Officers and regulatory representatives of Cepheid AB

KIRSEL Lena
Senior Manager of Regulatory Affairs Delegated Tasks/Duties: • The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date. • In the case of devices for performance studies intended to be used in the context of interventional clinical performance studies or other performance studies involving risks for the subjects, the statement referred to in Section 4.1 of Annex XIV is issued
Hidden
SEDLENIEKS Helena
Director Quality Systems The conformity of the device is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released. The post-market surveillance obligations are complied with in accordance with Article 10(9) The reporting obligations referred to in Article 82 to 86 are fulfilled.
Hidden

Statistics for Cepheid AB

2Total Devices

2Basic UDI-DIs

0Not destined for EU market

0Certificates

0Valid

0Expiring < 6 months

2Countries

Certificate health for Cepheid AB

No certificates registered for this manufacturer.

Devices by risk class

Device catalog for Cepheid AB

Showing 1–2 of 2 devices.

Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
Xpert®	`GXMRSA/SA-BC-CE-10`	`07332940000134`	1	On the market
Xpert®	`GXGI-CE-10`	`07332940009465`	1	On the market

Device families (Basic UDI-DI) of Cepheid AB

Showing 1–2 of 2 device families.

Market presence of Cepheid AB

Devices placed in 2 countries

Netherlands1
Sweden1

Cepheid AB

Cepheid AB

About Cepheid AB

Contact details for Cepheid AB

Competent authority

Officers and regulatory representatives of Cepheid AB

Certificate health for Cepheid AB

Related documents

Devices by risk class

Related searches

About Cepheid AB

Contact details for Cepheid AB

Competent authority

Officers and regulatory representatives of Cepheid AB

Statistics for Cepheid AB

Certificate health for Cepheid AB

Related documents

Devices by risk class

Device catalog for Cepheid AB

Device families (Basic UDI-DI) of Cepheid AB

Market presence of Cepheid AB

Related searches

Statistics for Cepheid AB

Device catalog for Cepheid AB

Device families (Basic UDI-DI) of Cepheid AB

Market presence of Cepheid AB