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Organization name
UDI-DI code
Reference / catalog number

ClampArt — Class IIb MDD by Profil Institut für…

MD Atlas
Profil Institut für Stoffwechselforschung GmbH

EUDAMED last updated this device on Jun 21, 2023

ClampArt

B-1312091CLAMPART030

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Profil Institut für Stoffwechselforschung GmbH
UDI-DI code: 1312091CLAMPART030
Reference / catalog number: ClampArt

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Manufacturer information

Organization name: Profil Institut für Stoffwechselforschung GmbH
SRN: DE-MF-000004950
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Mar 27, 2013	Still on market

Device identification

Trade name: not provided
UDI-DI code: 1312091CLAMPART030
Basic UDI-DI: B-1312091CLAMPART030
Reference / catalog number: ClampArt
Issuing entity: IFA

Classification

Risk category: Class IIb
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Das ClampArt-Gerät dient der Durchführung automatisierter Glukose-Clamps. Dafür wird einem Probanden vom ClampArt-Gerät kontinuierlich über einen peripheren Venenkatheter eine kleine Menge Blut abgenommen und die Blutglukosekonzentration bestimmt. Hieraus bestimmt der Regelalgorithmus des ClampArt-Gerätes minütlich diejenige Glukosemenge, die notwendig ist, um einen vorgegebenen Zielblutglukosewert zu erreichen. Über einen weiteren peripheren Venenkatheter wird dem Probanden vom ClampArt-Gerät die berechnete Glukosemenge infundiert. Die Dauer der Anwendung beträgt maximal 48 Stunden.
Additional information URL: https://www.profil.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12040199GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - OTHER

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

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.

Related devices

This device is not currently linked to any other device.