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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

GlucoTab R8.1 — Class IIa MDR by decide Clinical…

MD Atlas
decide Clinical Software GmbH

EUDAMED last updated this device on Aug 6, 2022

GlucoTab R8.1

918000023GT20-11AQG

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: decide Clinical Software GmbH
UDI-DI code: 09180000230032
Reference / catalog number: GlucoTab R8.1

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Manufacturer information

Organization name: decide Clinical Software GmbH
SRN: AT-MF-000001001
Manufacturer status: Active

Market distribution

Primary placement in Austria; available across 2 countries total.

Country	On market since	Until
AustriaPrimary placement	Aug 8, 2022	Still on market
Germany	Aug 8, 2022	Still on market

Device identification

Trade name: not provided
UDI-DI code: 09180000230032
Basic UDI-DI: 918000023GT20-11AQG
Reference / catalog number: GlucoTab R8.1
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12040292GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

GlucoTab R10.0918000023GT20-11AQGOn the market GlucoTab R10.1918000023GT20-11AQGOn the market GlucoTab R8.0918000023GT20-11AQGOn the market GlucoTab R9.0918000023GT20-11AQGOn the market GlucoTab R9.1918000023GT20-11AQGOn the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.