Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

Nursing blanket stretch standard… — Class I MDR by Fico bv

MD Atlas
Fico bv

EUDAMED last updated this device on Jun 23, 2023

Nursing blanket stretch standard without sleeves

5407010900701015F

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Fico bv
UDI-DI code: 05407010900019
Reference / catalog number: 070101

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

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: Nursing blanket stretch standard without sleeves
UDI-DI code: 05407010900019
Basic UDI-DI: 5407010900701015F
Reference / catalog number: 070101
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: Een verpleegdeken of fixatiedeken is de ideale oplossing om (on)rustige personen op een humane manier te immobiliseren zonder het gebruik van gordels of riemen en om hen toch zoveel mogelijk bewegingsvrijheid en bescherming te bieden. Zo kan hij zich nog steeds van positie veranderen, maar hij zal niet komen bloot te liggen, uit bed vallen of het incontinentiemateriaal stuktrekken.
Additional information URL: https://www.ficobelgium.eu/soft-fix/verpleegdekens/verpleegdeken-stretch
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

2 part nursing blanket FR&TR standard without sleeves without zip for tube access54070109007050163On the market Nursing blanket FR&TR Standard without sleeves without zip for tube access5407010900702015LOn the market Relax positioning cushions Standaard PU5407010900201003NOn the market Relax positioning cushions Visco filling5407010900401024GOn the market

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.