EUDAMED last updated this device on May 19, 2026

Humidity Temperature Control (HTC) Kit

42502895HELIOSGR

On the marketIVDR Class A

Applicable legislation: —
Organization name: Aesku.Diagnostics GmbH & Co. KG
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 →: 04250289512640
Reference / catalog number: REF.HTC-1001

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.

Humidity Temperature Control (HTC) Kit is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by Aesku.Diagnostics GmbH & Co. KG. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: Humidity Temperature Control (HTC) Kit
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 →: 04250289512640
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 →: 42502895HELIOSGR
Reference / catalog number: REF.HTC-1001
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 A
Applicable legislation: —
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.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)04250289512640

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.

W02069099VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

Caution
Consult instructions for use

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Germany; available across 16 countries total.

Country	On market since	Until
GermanyPrimary placement	May 25, 2022	Still on market
Austria	May 25, 2022	Still on market
Belgium	May 25, 2022	Still on market
Cyprus	May 25, 2022	Still on market
Spain	May 25, 2022	Still on market
Finland	May 25, 2022	Still on market
Croatia	May 25, 2022	Still on market
Ireland	May 25, 2022	Still on market
Liechtenstein	May 25, 2022	Still on market
Luxembourg	May 25, 2022	Still on market
Latvia	May 25, 2022	Still on market
Malta	May 25, 2022	Still on market
Netherlands	May 25, 2022	Still on market
Poland	May 25, 2022	Still on market
Romania	May 25, 2022	Still on market
Slovenia	May 25, 2022	Still on market

Related searches

IVDR Class A medical devices in EUDAMED

Device identification

Trade name: Humidity Temperature Control (HTC) Kit
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 →: 04250289512640
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 →: 42502895HELIOSGR
Reference / catalog number: REF.HTC-1001
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

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Certificates

No certificates registered for this manufacturer.

Market distribution

Primary placement in Germany; available across 16 countries total.

Country	On market since	Until
GermanyPrimary placement	May 25, 2022	Still on market
Austria	May 25, 2022	Still on market
Belgium	May 25, 2022	Still on market
Cyprus	May 25, 2022	Still on market
Spain	May 25, 2022	Still on market
Finland	May 25, 2022	Still on market
Croatia	May 25, 2022	Still on market
Ireland	May 25, 2022	Still on market
Liechtenstein	May 25, 2022	Still on market
Luxembourg	May 25, 2022	Still on market
Latvia	May 25, 2022	Still on market
Malta	May 25, 2022	Still on market
Netherlands	May 25, 2022	Still on market
Poland	May 25, 2022	Still on market
Romania	May 25, 2022	Still on market
Slovenia	May 25, 2022	Still on market

Humidity Temperature Control (HTC) Kit

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