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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

6145 01000, 6145 08000, 6145 01012 — Class I MDR

MD Atlas
Coolike Regnery GmbH

EUDAMED last updated this device on Apr 29, 2026

6145 01000, 6145 08000, 6145 01012

4010054R33424WC

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Coolike Regnery GmbH
UDI-DI code: 04010054009290
Reference / catalog number: 6145 01000, 6145 08000, 6145 01012

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View device family (Basic UDI)

Manufacturer information

Organization name: Coolike Regnery GmbH
SRN: DE-MF-000017788
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 04010054009290
Basic UDI-DI: 4010054R33424WC
Reference / catalog number: 6145 01000, 6145 08000, 6145 01012
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Bewahren Sie die Kompresse im Gefrierfach auf, so ist sie jederzeit einsetzbar. Vor der Anwendung in ein Tuch einschlagen. Anwendung bei Kindern nur unter Aufsicht von Erwachsenen. Nur zur Kaltanwendung geeignet!
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

EMDN nomenclature code(s)

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

Z120499GENERAL MEDICINE 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

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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.