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CARDEA GmbH & Co. KG

Germany DE-MF-000006460 Last updated 8 Jun 2026

Devices
131
Registries
EUDAMED
FDA recalls
0

Catalogue131

Page 1 of 3

Showing 1-50 of 131

EUDAMED certificates1

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

EUDAMED certificates (1)

Notified body 0483 1 certificate

  • D1439300014 Supplemented

    Quality management system EU MDR

    Issued
    28 Jul 2026
    Expires
    15 Mar 2027
    Reason
    Add device or group

Related companies

Notified bodies

  • Notified body 0483

What CARDEA GmbH & Co. KG makes

CARDEA GmbH & Co. KG manufactures high‑pressure connector systems under the Transaflow brand, including straight connectors of 120 cm, 150 cm, 200 cm and 240 cm lengths, as well as versions equipped with a rotation adapter in the same size range. The product line also includes the RöKo‑Safety‑Line 250h device.

All of these devices are classified as Class IIa medical devices and are listed in the European Union database (Eudamed). The company is based in Germany.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does CARDEA GmbH & Co. KG manufacture?

CARDEA produces high‑pressure connector systems under the Transaflow brand, offering straight connectors in lengths of 120 cm, 150 cm, 200 cm and 240 cm, as well as versions with a rotation adapter in the same size range. The portfolio also includes the RöKo‑Safety‑Line 250h device, all designed for medical fluid handling.

Where is CARDEA GmbH & Co. KG located and which regulatory database lists its devices?

The company is based in Germany, as indicated by the country code DE. All of its devices are listed in the European Union’s medical device database, Eudamed, which provides public information on devices placed on the EU market.

How are CARDEA’s devices classified under EU medical device regulations?

Each device in CARDEA’s catalogue, including the Transaflow connectors and the RöKo‑Safety‑Line 250h, is assigned to Class IIa. This classification reflects a moderate level of risk and requires conformity assessment by a notified body before the device can be placed on the market.

Which specific product families are included in CARDEA’s high‑pressure connector line?

The high‑pressure connector line consists of the Transaflow series, which offers straight connectors of 120 cm, 150 cm, 200 cm and 240 cm, and the same lengths equipped with a rotation adapter. These variants provide flexibility for different clinical setups while maintaining the same Class IIa classification.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
Germany(from SRN)
Address
9, Am Schützenkrug, Harsleben, Germany
Website
cardea-med.de
Phone
0049 39424 940090
PRRC contact
Kai Stolpe
EUDAMED SRN
DE-MF-000006460