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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

MONOP85B — Class I MDR by ZiboCare A/S

MD Atlas
ZiboCare A/S

EUDAMED last updated this device on Apr 17, 2026

MONOP85B

5715841043306MFAKK

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ZiboCare A/S
UDI-DI code: 05715841501757
Reference / catalog number: MONOP85B

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Manufacturer information

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

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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.

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	Mar 6, 2023	Still on market

Device identification

Trade name: not provided
UDI-DI code: 05715841501757
Basic UDI-DI: 5715841043306MFAKK
Reference / catalog number: MONOP85B
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