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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

SP 103 — Class I MDR by Lomed Nederland

MD Atlas
Lomed Nederland

EUDAMED last updated this device on Jan 8, 2024

SP 103

8718873SP1035M

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Lomed Nederland
UDI-DI code: 08718873036973
Reference / catalog number: SP 103

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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: 08718873036973
Basic UDI-DI: 8718873SP1035M
Reference / catalog number: SP 103
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: Deze Digisleeve is een voordelige manier om twee vingers naast elkaar te positioneren zonder gebruik te maken van tape. De Digisleeve spalk wordt gebruikt om het genezingsproces te versnellen en stijfheid van de gewrichten te voorkomen. Om de juiste maat te bepalen dient de omtrek van de gewonde vinger gemeten te worden.
Additional information URL: https://www.lomed.nl/assortiment/digi-sleeve/
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.

Y060603FINGERS 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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