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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

10-007745B — Class I MDR by ZiboCare A/S

MD Atlas
ZiboCare A/S

EUDAMED last updated this device on Apr 16, 2026

10-007745B

5715841043306MFAKK

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ZiboCare A/S
UDI-DI code: 05715841500163
Reference / catalog number: 10-007745B

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Manufacturer information

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

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 1 country total.

Country	On market since	Until
DenmarkPrimary placement	Jan 31, 2020	Still on market

Device identification

Trade name: not provided
UDI-DI code: 05715841500163
Basic UDI-DI: 5715841043306MFAKK
Reference / catalog number: 10-007745B
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 accessory
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

Related devices

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