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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

IncoGlide — Class I MDR by DecoCare

MD Atlas
DecoCare

EUDAMED last updated this device on Jul 25, 2024

IncoGlide

87209382653211XZ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: DecoCare
UDI-DI code: 08720938265280
Reference / catalog number: 3212

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View device family (Basic UDI)

Manufacturer information

Organization name: DecoCare
SRN: NL-MF-000015695
Manufacturer status: Active

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW007
Het product niet gebruiken bij beschadiging.
CW010
Lees voor gebruik de gebruiksaanwijzing.

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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: IncoGlide
UDI-DI code: 08720938265280
Basic UDI-DI: 87209382653211XZ
Reference / catalog number: 3212
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 IncoGlide is een herbruikbaar ergonomisch hulpmiddel om cliënten met incontinentie problematiek veilig en comfortabel te verplaatsen of te positioneren. Comfort en gemak voor cliënt en verzorging. IncoGlide vereenvoudigt verplaatsing van cliënten in de linker en rechter richting, maar voorkomt onderuitzakken door een stroevende werking. [NL] Deze versie van de IncoGlide is verbreed, zodat zwaarlijvige en brede personen er goed op blijven liggen tijdens het wisselen van de houding.
Additional information URL: https://decocare.nl/producten/transfer/incoglide.html
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08720938265280

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

T0499INCONTINENCE DEVICES - 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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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.