EUDAMED last updated this device on Aug 10, 2026

5006347

B-09120036863576

On the marketIVDD — General

Applicable legislation: —
Organization name: Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 09120036863576
Reference / catalog number: 5006347

Regulatory classification unavailableThis product's Basic UDI record hasn't been published in EUDAMED yet. Classification and compliance details will appear automatically once EUDAMED publishes it.

5006347 is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH. Placed on the EU market in Austria. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: not provided
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 09120036863576
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: B-09120036863576
Reference / catalog number: 5006347
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: GS1

Classification

Risk category: IVDD — General
Applicable legislation: —
Status: On the market

Device details

Quantity: 1
Additional product description: Ceveron TGA CAL is used for establishing a thrombin calibration curve on Ceveron alpha TGA and instruments of the Ceveron 100 series with fluorogenic channels, to be used with Ceveron TGA RB, Ceveron TGA RC Low and Ceveron TGA RC High.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)09120036863576

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

W0103020701CALIBRATION PLASMA FOR HAEMOSTASIS

Critical warnings

No critical warnings reported for this device.

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Austria; available across 32 countries total.

Country	On market since	Until
AustriaPrimary placement	Sep 22, 2014	Still on market
Belgium	Sep 22, 2014	Still on market
Bulgaria	Sep 22, 2014	Still on market
Cyprus	Sep 22, 2014	Still on market
Czechia	Sep 22, 2014	Still on market
Germany	Sep 22, 2014	Still on market
Denmark	Sep 22, 2014	Still on market
Estonia	Sep 22, 2014	Still on market
EL	Sep 22, 2014	Still on market
Spain	Sep 22, 2014	Still on market
Finland	Sep 22, 2014	Still on market
France	Sep 22, 2014	Still on market
Croatia	Sep 22, 2014	Still on market
Hungary	Sep 22, 2014	Still on market
Ireland	Sep 22, 2014	Still on market
Iceland	Sep 22, 2014	Still on market
Italy	Sep 22, 2014	Still on market
Liechtenstein	Sep 22, 2014	Still on market
Lithuania	Sep 22, 2014	Still on market
Luxembourg	Sep 22, 2014	Still on market
Latvia	Sep 22, 2014	Still on market
Malta	Sep 22, 2014	Still on market
Netherlands	Sep 22, 2014	Still on market
Norway	Sep 22, 2014	Still on market
Poland	Sep 22, 2014	Still on market
Portugal	Sep 22, 2014	Still on market
Romania	Sep 22, 2014	Still on market
Sweden	Sep 22, 2014	Still on market
Slovenia	Sep 22, 2014	Still on market
Slovakia	Sep 22, 2014	Still on market
Türkiye	Sep 22, 2014	Still on market
XI	Sep 22, 2014	Still on market

Related searches

IVDD — General medical devices in EUDAMED

Device identification

Trade name: not provided
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 09120036863576
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: B-09120036863576
Reference / catalog number: 5006347
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: GS1

Device details

Quantity: 1
Additional product description: Ceveron TGA CAL is used for establishing a thrombin calibration curve on Ceveron alpha TGA and instruments of the Ceveron 100 series with fluorogenic channels, to be used with Ceveron TGA RB, Ceveron TGA RC Low and Ceveron TGA RC High.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Certificates

No certificates registered for this manufacturer.

Market distribution

Primary placement in Austria; available across 32 countries total.

Country	On market since	Until
AustriaPrimary placement	Sep 22, 2014	Still on market
Belgium	Sep 22, 2014	Still on market
Bulgaria	Sep 22, 2014	Still on market
Cyprus	Sep 22, 2014	Still on market
Czechia	Sep 22, 2014	Still on market
Germany	Sep 22, 2014	Still on market
Denmark	Sep 22, 2014	Still on market
Estonia	Sep 22, 2014	Still on market
EL	Sep 22, 2014	Still on market
Spain	Sep 22, 2014	Still on market
Finland	Sep 22, 2014	Still on market
France	Sep 22, 2014	Still on market
Croatia	Sep 22, 2014	Still on market
Hungary	Sep 22, 2014	Still on market
Ireland	Sep 22, 2014	Still on market
Iceland	Sep 22, 2014	Still on market
Italy	Sep 22, 2014	Still on market
Liechtenstein	Sep 22, 2014	Still on market
Lithuania	Sep 22, 2014	Still on market
Luxembourg	Sep 22, 2014	Still on market
Latvia	Sep 22, 2014	Still on market
Malta	Sep 22, 2014	Still on market
Netherlands	Sep 22, 2014	Still on market
Norway	Sep 22, 2014	Still on market
Poland	Sep 22, 2014	Still on market
Portugal	Sep 22, 2014	Still on market
Romania	Sep 22, 2014	Still on market
Sweden	Sep 22, 2014	Still on market
Slovenia	Sep 22, 2014	Still on market
Slovakia	Sep 22, 2014	Still on market
Türkiye	Sep 22, 2014	Still on market
XI	Sep 22, 2014	Still on market

5006347

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Market distribution

Related searches

Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates

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