EUDAMED last updated this device on Aug 10, 2026

Coagulation CON AK

912003686TC2B0000001TZ

On the marketIVDR Class C

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 →: 09120036860131
Reference / catalog number: 5011050

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.

Coagulation CON AK is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class C. 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: Coagulation CON AK
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 →: 09120036860131
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 →: 912003686TC2B0000001TZ
Reference / catalog number: 5011050
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: IVDR Class C
Applicable legislation: —
Status: On the market

Device details

Quantity: 1
Additional product description: Coagulation CON AK is an in vitro diagnostic control plasma intended for the assessment of accuracy and precision of prothrombin time (PT) determinations in the therapeutic range of oral anticoagulant therapy.
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)09120036860131

UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

EMDN nomenclature code(s)

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

W0103020702CONTROL 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	Jun 30, 2026	Still on market
Belgium	Jun 30, 2026	Still on market
Bulgaria	Jun 30, 2026	Still on market
Cyprus	Jun 30, 2026	Still on market
Czechia	Jun 30, 2026	Still on market
Germany	Jun 30, 2026	Still on market
Denmark	Jun 30, 2026	Still on market
Estonia	Jun 30, 2026	Still on market
EL	Jun 30, 2026	Still on market
Spain	Jun 30, 2026	Still on market
Finland	Jun 30, 2026	Still on market
France	Jun 30, 2026	Still on market
Croatia	Jun 30, 2026	Still on market
Hungary	Jun 30, 2026	Still on market
Ireland	Jun 30, 2026	Still on market
Iceland	Jun 30, 2026	Still on market
Italy	Jun 30, 2026	Still on market
Liechtenstein	Jun 30, 2026	Still on market
Lithuania	Jun 30, 2026	Still on market
Luxembourg	Jun 30, 2026	Still on market
Latvia	Jun 30, 2026	Still on market
Malta	Jun 30, 2026	Still on market
Netherlands	Jun 30, 2026	Still on market
Norway	Jun 30, 2026	Still on market
Poland	Jun 30, 2026	Still on market
Portugal	Jun 30, 2026	Still on market
Romania	Jun 30, 2026	Still on market
Sweden	Jun 30, 2026	Still on market
Slovenia	Jun 30, 2026	Still on market
Slovakia	Jun 30, 2026	Still on market
Türkiye	Jun 30, 2026	Still on market
XI	Jun 30, 2026	Still on market

Related searches

IVDR Class C medical devices in EUDAMED

Device identification

Trade name: Coagulation CON AK
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 →: 09120036860131
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 →: 912003686TC2B0000001TZ
Reference / catalog number: 5011050
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: Coagulation CON AK is an in vitro diagnostic control plasma intended for the assessment of accuracy and precision of prothrombin time (PT) determinations in the therapeutic range of oral anticoagulant therapy.
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	Jun 30, 2026	Still on market
Belgium	Jun 30, 2026	Still on market
Bulgaria	Jun 30, 2026	Still on market
Cyprus	Jun 30, 2026	Still on market
Czechia	Jun 30, 2026	Still on market
Germany	Jun 30, 2026	Still on market
Denmark	Jun 30, 2026	Still on market
Estonia	Jun 30, 2026	Still on market
EL	Jun 30, 2026	Still on market
Spain	Jun 30, 2026	Still on market
Finland	Jun 30, 2026	Still on market
France	Jun 30, 2026	Still on market
Croatia	Jun 30, 2026	Still on market
Hungary	Jun 30, 2026	Still on market
Ireland	Jun 30, 2026	Still on market
Iceland	Jun 30, 2026	Still on market
Italy	Jun 30, 2026	Still on market
Liechtenstein	Jun 30, 2026	Still on market
Lithuania	Jun 30, 2026	Still on market
Luxembourg	Jun 30, 2026	Still on market
Latvia	Jun 30, 2026	Still on market
Malta	Jun 30, 2026	Still on market
Netherlands	Jun 30, 2026	Still on market
Norway	Jun 30, 2026	Still on market
Poland	Jun 30, 2026	Still on market
Portugal	Jun 30, 2026	Still on market
Romania	Jun 30, 2026	Still on market
Sweden	Jun 30, 2026	Still on market
Slovenia	Jun 30, 2026	Still on market
Slovakia	Jun 30, 2026	Still on market
Türkiye	Jun 30, 2026	Still on market
XI	Jun 30, 2026	Still on market

Coagulation CON AK

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI 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

UDI-PI 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 covering this device

Related devices

Certificates