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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

Bioserenity Cloud — Class IIa MDR by BIOSERENITY MEDICAL…

MD Atlas
BIOSERENITY MEDICAL DEVICES GROUP

EUDAMED last updated this device on Dec 22, 2025

Bioserenity Cloud

361522BiosCloudV09X

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: BIOSERENITY MEDICAL DEVICES GROUP
UDI-DI code: 03615220004362
Reference / catalog number: 1012-21001-UN

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Manufacturer information

Organization name: BIOSERENITY MEDICAL DEVICES GROUP
SRN: FR-MF-000039391
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.

Market distribution

Primary placement in France; available across 2 countries total.

Country	On market since	Until
FrancePrimary placement	Jun 1, 2023	Dec 22, 2025
Liechtenstein	Aug 22, 2024	Dec 22, 2025

Device identification

Trade name: Bioserenity Cloud
UDI-DI code: 03615220004362
Basic UDI-DI: 361522BiosCloudV09X
Reference / catalog number: 1012-21001-UN
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: N/A
Additional information URL: https://bioserenity.com/quality-europe/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12040182GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES

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

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Software identification