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SCOPIO LABS LTD

Israel IL-MF-000025129 Last updated 23 Oct 2026

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Devices
10
Registries
EUDAMEDGUDIDFDA 510(k)FDA
FDA recalls
0

Catalogue10

EUDAMED certificates1

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

EUDAMED certificates (1)

Notified body 2797 1 certificate

  • IVDR 797359 Amended

    Quality management system EU IVDR

    Issued
    27 Nov 2025
    Expires
    13 Nov 2030
    Reason
    Other

Related companies

Authorised representatives

Notified bodies

  • Notified body 2797

What SCOPIO LABS LTD makes

Scopio Labs Ltd manufactures the X100 and X100HT series of digital scanners and processing units, including configurations with Full Field Peripheral Blood Smear (PBS) and Full Field Bone Marrow Aspirate (BMA) applications, which are used for automated hematology and pathology sample analysis.

These devices are classified as Class B, Class II, and IVD General, and are listed in the EUDAMED and FDA 510(k) registries; the company is based in Israel (IL).

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

Frequently asked questions

What types of products does Scopio Labs Ltd manufacture?

Scopio Labs Ltd produces the X100 and X100HT series of digital scanners and processing units. These include configurations equipped for Full Field Peripheral Blood Smear (PBS) and Full Field Bone Marrow Aspirate (BMA) applications, which are intended for automated analysis of hematology and pathology samples. The answer is based on the listed example devices and summary.

Where is Scopio Labs Ltd headquartered?

The company is based in Israel, as indicated by the country code IL in the provided data. This location information comes directly from the COMPANY and COUNTRY fields, so no other inference is required.

In which regulatory registries are Scopio Labs Ltd's devices listed?

Scopio Labs Ltd’s devices appear in the European EUDAMED database and the U.S. FDA 510(k) registry. This is explicitly stated under the LISTED IN field, confirming the two registries where the X100 and X100HT series are recorded.

How are the X100 and X100HT devices classified under regulatory categories?

The devices are classified as Class B, Class II, and IVD General. These classifications are taken directly from the DEVICE CLASSES entry, indicating the regulatory categories applied to the digital scanners and processing units.

What clinical applications are supported by Scopio Labs Ltd's X100 series?

The X100 series supports Full Field Peripheral Blood Smear (PBS) and Full Field Bone Marrow Aspirate (BMA) applications, enabling automated analysis of blood smears and bone marrow samples. This is derived from the device names and the summary describing their use in hematology and pathology sample analysis.

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

Information

Country
Israel
Address
10, Hasharon, Tel Aviv, Israel
PRRC contact
Orly Schwartz
EUDAMED SRN
IL-MF-000025129
FDA FEI number
3018182832
DUNS number
600369986