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Organization name
UDI-DI code
Reference / catalog number

PO HCB00 — Class I MDR by Lomed Nederland

MD Atlas
Lomed Nederland

EUDAMED last updated this device on Nov 15, 2023

PO HCB00

8718873HCB00Z8

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Lomed Nederland
UDI-DI code: 08718873036898
Reference / catalog number: PO HCB00

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View device family (Basic UDI)

Manufacturer information

Organization name: Lomed Nederland
SRN: NL-MF-000032807
Manufacturer status: Active

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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.

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Netherlands; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 08718873036898
Basic UDI-DI: 8718873HCB00Z8
Reference / catalog number: PO HCB00
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: Voordelen van koudetherapie Koudetherapie wordt aanbevolen om verwondingen met een therapeutisch effect te helpen. In de meeste gevallen is koudetherapie de eerste hulp die direct wordt toegepast bij sportgerelateerde blessures. Dit zorgt ervoor dat de zwelling afneemt, ontstekingen worden geminimaliseerd en pijn en ongemak worden verminderd. Overschakelen van warme naar koude therapie kan ook helpen bij genezing nadat de eerste warme of koude toepassing is aangebracht. Voordelen van warmtetherapie Warmtetherapie stimuleert de bloedvaten om te verwijden, waardoor de bloedcirculatie toeneemt. Verhoogde bloedcirculatie brengt een toevoer van zuurstof en voedingsstoffen naar de specifieke weefsels waar de warmtebron wordt toegepast. Dit stimuleert op zijn beurt de verwijdering van celafval. Spierspasmen die kunnen optreden, moeten afnemen na het toepassen van warmtetherapie.
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.

M03050299BANDAGES AND SPLINTS - 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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