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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 3119-B — Class I MDR by Lomed Nederland

MD Atlas
Lomed Nederland

EUDAMED last updated this device on Nov 15, 2023

PO 3119-B

87188733119BN2

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Lomed Nederland
UDI-DI code: 08718873036607
Reference / catalog number: PO 3119-B

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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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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: 08718873036607
Basic UDI-DI: 87188733119BN2
Reference / catalog number: PO 3119-B
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 Pro Orthic Manulacer is gemaakt van hoogwaardige, ademende materialen voor meer draagcomfort voor de patiënt. De verstelbare aluminium spalk in combinatie met het vetersysteem zorgen voor een goede stabilisatie van het polsgewricht.
Additional information URL: https://www.lomed.nl/assortiment/pro-orthic-manulacer/
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.

Y060612WRIST-HAND 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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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.