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

8520014MONORP — Class I MDR by ZiboCare A/S

MD Atlas
ZiboCare A/S

EUDAMED last updated this device on Apr 10, 2026

8520014MONORP

5715841043306MFLW

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ZiboCare A/S
UDI-DI code: 05715841502792
Reference / catalog number: 8520014MONORP

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: ZiboCare A/S
SRN: DK-MF-000045317
Manufacturer status: Active

Related devices

7000324015715841042809DPC1QFOn the market 7000324025715841042809DPC1QFOn the market 7000324035715841042809DPC1QFOn the market BARI2001005715841043306MFLWOn the market 81468745715841043306MFLWOn the market

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Denmark; available across 2 countries total.

Country	On market since	Until
DenmarkPrimary placement	Aug 6, 2020	Still on market
Norway	Jan 24, 2025	Still on market

Device identification

Trade name: not provided
UDI-DI code: 05715841502792
Basic UDI-DI: 5715841043306MFLW
Reference / catalog number: 8520014MONORP
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: Foam Mattress
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y99DEVICES FOR PERSONS WITH DISABILITIES NOT INCLUDED IN OTHER CATEGORIES - 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

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.