SSMD001E

by Sugentech, Inc. South Korea EUDAMED

Ref SSMD001EModel Surearly SMART

EMDN W020101020101

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number88094088SSM-001Y2 Basic UDI-DI	Date3 Aug 2025Registered	StatusActive

Coverage

1 jurisdiction

Active
Not covered

European Union — CE/IVDR Active

Certificates

2 certificates · EUDAMED

CR-04-1273-919-26 Issued

Technical documentation EU IVDR

Notified body

Eurofins Electric & Electronics Finland Oy 0537

Issued
12 Aug 2026

Expires
20 Jan 2030
V74 002704 0025 Withdrawn

Technical documentation EU IVDR

Notified body

TÜV SÜD Product Service GmbH 0123

Issued
24 Jan 2025

Expires
20 Jan 2030

Reason
Transferred to other nb

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference: Surearly SMART, SSMD001E

Primary DI / UDI-DI: 08809408862591
Basic UDI-DI: 88094088SSM-001Y2
EMDN Code: W020101020101 Urine strip readers

Device Class: Class B
Market of Registration: Spain

Manufacturer details

EUDAMED SRN: KR-MF-000023952
Authorised representative: Medical Technology Promedt Consulting GmbH DE-AR-000000085

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Properties & raw data

Show properties, registry sources and raw records

Self Testing
Surgical Instrument

Other properties (9)

Sterile: No
Human Tissues: No
Animal Tissues: No
Microbial Substances: No
Reagent: No
Near-Patient Testing: No
Professional Testing: No
Companion Diagnostics: No
New Device: No

Sources (1)

EUDAMED 08809408862591|88094088SSM-001Y2 61 fields · synced 25 Oct 2026