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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

Hot and Cold compress — Class I MDR by Coolike Regnery GmbH

MD Atlas
Coolike Regnery GmbH

EUDAMED last updated this device on Jun 19, 2024

Hot and Cold compress

4010054R35153WJ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Coolike Regnery GmbH
UDI-DI code: 04010054009344
Reference / catalog number: 6094 01001, 6094 08001

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Manufacturer information

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

Market distribution

Primary placement in Germany; available across 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Device identification

Trade name: Hot and Cold compress
UDI-DI code: 04010054009344
Basic UDI-DI: 4010054R35153WJ
Reference / catalog number: 6094 01001, 6094 08001
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: Anwendung bei Kindern nur unter Aufsicht von Erwachsenen. Bitte beiliegende Anwendungshinweise beachten.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

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

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

6093 01000, 6095 01000, 6173 08000, 6225 08000, 6100 08000, 6094 08000, 6115 010004010054R33424WCOn the market