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String Polska Sp. z o.o.

Poland PL-MF-000035907 Last updated 17 Sep 2026

Devices
2
Registries
EUDAMED
FDA recalls
0

Catalogue2

  • OPUS1 Ref 12CHECGOPUS1

    Class IIa EUDAMED Active
  • OPUS mini Ref 12CHECGOPUSM

    Class IIa EUDAMED Active

EUDAMED certificates1

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

EUDAMED certificates (1)

TUV NORD Polska Sp. z o.o 2274 1 certificate

  • TNP/MDR/0052/4887/2026 Issued

    Quality management system EU MDR

    Issued
    10 Mar 2026
    Expires
    9 Mar 2029

Notified bodies

About

Medical apparatus that combines precision with intuition. Excellent equipment for modern medical facility and for professionals.

Translated from the manufacturer's own website. Source

What String Polska Sp. z o.o. makes

String Polska Sp. z o.o. manufactures OPUS1 and OPUS mini, which are medical imaging devices designed for diagnostic use in clinical settings. These devices appear to be ultrasound systems, likely intended for general medical imaging tasks such as obstetrics, gynecology, or abdominal scanning, based on their naming conventions and typical Class IIa classification.

The company’s devices are classified under EU Medical Device Regulation as Class IIa and are registered in the EU’s eudamed database. String Polska Sp. z o.o. is based in Poland.

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 String Polska Sp. z o.o. manufacture?

String Polska Sp. z o.o. manufactures OPUS1 and OPUS mini, which are medical imaging devices. Based on their naming conventions and typical classification, these devices are likely ultrasound systems used for diagnostic purposes in clinical settings, such as obstetrics, gynecology, or abdominal imaging.

Where is String Polska Sp. z o.o. based?

String Polska Sp. z o.o. is based in Poland, as indicated by its company name and location data.

Which regulatory registries list String Polska Sp. z o.o.’s devices?

String Polska Sp. z o.o.’s devices are listed in the EU’s eudamed database, which is the official registry for medical devices under the EU Medical Device Regulation. This ensures transparency and traceability of their products within the European market.

How are String Polska Sp. z o.o.’s devices classified under EU regulations?

String Polska Sp. z o.o.’s devices, including OPUS1 and OPUS mini, are classified as Class IIa under the EU Medical Device Regulation. This classification is typically assigned to devices with a moderate risk level, requiring additional measures like design controls and risk management to ensure safety and performance.

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

Information

Country
Poland
Address
135, Jasnogórska, Kraków, Poland
Phone
+48124420134
PRRC contact
Maciej Gocyla
EUDAMED SRN
PL-MF-000035907