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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

EB PO 1105 — Class I MDR by Lomed Nederland

MD Atlas
Lomed Nederland

EUDAMED last updated this device on Jan 8, 2024

EB PO 1105

8718873EBPO11054D

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Lomed Nederland
UDI-DI code: 08718873037048
Reference / catalog number: EB PO 1105

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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: 08718873037048
Basic UDI-DI: 8718873EBPO11054D
Reference / catalog number: EB PO 1105
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: Telescopisch in lengte verstelbaar. De bekleding op de sluitingen voorkomt schuiven. De aluminium manchetten zijn aan te passen aan de anatomie van de gebruiker. Incl. praktische sling voor ontlasten van de nek en schouder.
Additional information URL: https://www.lomed.nl/assortiment/rom-elleboogbrace/
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.

Y060615ELBOW 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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