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Organization name
UDI-DI code
Reference / catalog number

2 part nursing blanket FR&TR… — Class I MDR by Fico bv

MD Atlas
Fico bv

EUDAMED last updated this device on Jun 27, 2023

2 part nursing blanket FR&TR standard without sleeves without zip for tube access

54070109007050163

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Fico bv
UDI-DI code: 05407010900026
Reference / catalog number: 070501

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Manufacturer information

Organization name: Fico bv
SRN: BE-MF-000033687
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW007
Raadpleeg voor gebruik de gebruiksaanwijzing: Lees voor gebruik de gebruiksaanwijzing.

Market distribution

Primary placement in Belgium; available across 1 country total.

Placed on the market in Belgium; per-country availability dates not published.

Device identification

Trade name: 2 part nursing blanket FR&TR standard without sleeves without zip for tube access
UDI-DI code: 05407010900026
Basic UDI-DI: 54070109007050163
Reference / catalog number: 070501
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 verpleegdekens voorkomen bloot liggen, uit bed vallen en het stuk trekken van incontinentie materiaal. Bij het 2 delig verpleegdeken wordt het zwarte deel onder de matras gelegd en verankerd aan het bedframe (dit deel blijft altijd liggen) en dicht geritst aan het lichtblauwe bovenste deel waar de patiënt onder ligt. Dit bovenste deel kan afgeritst worden voor reiniging. Het 2-delig verpleegdeken FR is voor zeer onrustige patiënten waar er een risico is dat de patiënt de matras om trekt.
Additional information URL: https://www.ficobelgium.eu/soft-fix/2-delig-verpleegdekens/fire-resist
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - 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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

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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.