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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

PO NS100 — Class I MDR by Lomed Nederland

MD Atlas
Lomed Nederland

EUDAMED last updated this device on Nov 15, 2023

PO NS100

8718873NS100W3B

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Lomed Nederland
UDI-DI code: 08718873036904
Reference / catalog number: PO NS100

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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: 08718873036904
Basic UDI-DI: 8718873NS100W3B
Reference / catalog number: PO NS100
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: De Night Sock van Pro Orthic is een nachtspalk voor het bevorderen van het herstel van hielspoor, peesplaatontsteking (fasciitis plantaris) en/of klachten aan de achillespees. Het nieuwe ontwerp zorgt voor een verbeterd en optimaal draagcomfort, waarbij de tenen bewegingsvrijheid houden en daarmee, anders dan bij de originele, geen onprettige positie aannemen. Met een verstelbare band wordt er een optimale rek verkregen. Dankzij de unieke bandconstructie wordt de voet in de juiste positie geplaatst, waarmee lichte rek op de peesplaat wordt uitgeoefend. Dit voorkomt verkorting en verkleving van de peesplaat. Door de twee verstelbare banden is de hielspoor sok van Pro Orthic uniek in zijn soort.
Additional information URL: https://www.lomed.nl/assortiment/pro-orthic-night-sock/
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.

Y06120602ENERGY RETURN ANKLE-FOOT ORTHOSES

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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