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NORMAGRUP TECHNOLOGY, S.A.

Spain ES-MF-000013355 Last updated 17 Sep 2026

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Devices
35
Registries
EUDAMED
FDA recalls
0

Catalogue35

  • Ardys Ref Ardys

    Class IIb EUDAMED Active

  • Ardys-Plus Ref Ardys-VL1P

    Class IIb EUDAMED Active

  • Ardys-Plus Ref Ardys-L1P

    Class IIb EUDAMED Active

  • Ardys-Plus Ref Ardys-R3P

    Class IIb EUDAMED Active

  • Ardys-Plus Ref Ardys-LR3P

    Class IIb EUDAMED Active

  • Ardys-Plus Ref Ardys-V1P

    Class IIb EUDAMED Active

  • Ardys Ref Ardys-DS

    Class IIb EUDAMED Active

  • Ardys Ref Ardys-S

    Class IIb EUDAMED Active

  • Neos Ref Neos-S

    Class IIb EUDAMED Active

  • Ardys-Plus Ref Ardys-V2P

    Class IIb EUDAMED Active

  • Neos Ref Neos-D

    Class IIb EUDAMED Active

  • Ardys-Plus Ref Ardys-L2P

    Class IIb EUDAMED Active

  • Ardys-Plus Ref Ardys-DL1PL

    Class IIb EUDAMED Active

  • Uci-Oval Ref UCI-OVAL

    Class IIb EUDAMED Active

  • Ardys-Plus Ref Ardys-1P

    Class IIb EUDAMED Active

  • Ardys-Plus Ref Ardys-LR1PL

    Class IIb EUDAMED Active

  • Ardys-Plus Ref Ardys-L2PL

    Class IIb EUDAMED Active

  • Ardys Ref Ardys-D

    Class IIb EUDAMED Active

  • Ardys-Plus Ref Ardys-LR2PL

    Class IIb EUDAMED Active

  • Ardys-Plus Ref Ardys-VL1PL

    Class IIb EUDAMED Active

  • Ardys-Plus Ref Ardys-DL2PL

    Class IIb EUDAMED Active

  • Ardys-Plus Ref Ardys-VR1P

    Class IIb EUDAMED Active

  • Neos Ref Neos-DS

    Class IIb EUDAMED Active

  • Ardys-Plus Ref Ardys-V3P

    Class IIb EUDAMED Active

  • Ardys-Plus Ref Ardys-L1PL

    Class IIb EUDAMED Active

  • Ardys-Plus Ref Ardys-DL3PL

    Class IIb EUDAMED Active

  • Ardys-Plus Ref Ardys-VL2P

    Class IIb EUDAMED Active

  • Ardys-Plus Ref Ardys-LR2P

    Class IIb EUDAMED Active

  • Ardys Ref Ardys-PD

    Class IIb EUDAMED Active

  • Ardys-Plus Ref Ardys-VL3PL

    Class IIb EUDAMED Active

  • Neos Ref Neos

    Class IIb EUDAMED Active

  • Ardys-Plus Ref Ardys-VLR1PL

    Class IIb EUDAMED Active

  • Ardys-Plus Ref Ardys-LR1P

    Class IIb EUDAMED Active

  • Ardys-Plus Ref Ardys-DL2P

    Class IIb EUDAMED Active

  • Ardys-Plus Ref Ardys-VLR1P

    Class IIb EUDAMED Active

About

Our first development was an emergency light and, from then on, our concern on security has been a motto in Normagrup.

From the manufacturer's own website. Source

What NORMAGRUP TECHNOLOGY, S.A. makes

Normagrup Technology, S.A. manufactures the ARDYS and UCI-OVAL devices, which appear to be medical instruments used for diagnostic or monitoring purposes in a clinical setting. The ARDYS and ARDYS-PLUS variants suggest variations or upgrades of the same core product line, likely intended for specific patient assessments or procedural applications. The UCI-OVAL device may serve a distinct function, potentially related to cardiovascular or respiratory diagnostics.

The company’s devices are classified as Class IIb under EU regulations and are listed in the eudamed database. The portfolio is regulated under the Medical Device Regulation (MDR) framework, ensuring compliance with EU standards for safety and performance. The manufacturer is based in Spain.

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 Normagrup Technology, S.A. manufacture?

Normagrup Technology, S.A. manufactures devices primarily used in clinical diagnostics or monitoring. The company produces the ARDYS and ARDYS-PLUS series, which appear to be variations of a core product line, likely designed for specific patient assessments or procedural applications. Additionally, they manufacture the UCI-OVAL device, which may serve a distinct purpose, potentially in cardiovascular or respiratory diagnostics. These devices are intended for use in regulated medical environments.

Where is Normagrup Technology, S.A. based, and how does this affect its regulatory compliance?

Normagrup Technology, S.A. is based in Spain, an EU member state. This positioning means its devices are subject to EU Medical Device Regulation (MDR) requirements, ensuring they meet strict safety, performance, and traceability standards. Since the company’s products are listed in eudamed, the EU’s medical device registry, they are part of the regulated medical device ecosystem within the European Union.

Which regulatory registries list Normagrup Technology, S.A.’s devices, and why is this important?

Normagrup Technology, S.A.’s devices are listed in eudamed, the official EU database for medical devices. This registry is crucial because it ensures transparency in the supply chain, allows healthcare providers and authorities to verify device compliance with MDR requirements, and facilitates traceability for post-market surveillance. Listing in eudamed confirms the devices meet EU regulatory standards for safety and performance.

How are Normagrup Technology, S.A.’s devices classified under EU regulations, and what does this classification mean?

Normagrup Technology, S.A.’s devices are classified as Class IIb under EU regulations. This classification indicates they pose a moderate to high risk to patients and require rigorous pre-market evaluation, including clinical data to demonstrate safety and performance. Class IIb devices must comply with specific technical documentation requirements and undergo conformity assessment procedures before being placed on the market.

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

Information

Country
Spain
Address
PARCELA 10, PARQUE TECNOLÓGICO DE ASTURIAS, LLANERA (ASTURIAS), Spain
Phone
+34985267100
PRRC contact
MIGUEL ANGEL GARCÍA
EUDAMED SRN
ES-MF-000013355