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Organization name
UDI-DI code
Reference / catalog number

OVU-KR-2 — Class IIa MDR by VivoSensMedical GmbH

MD Atlas
VivoSensMedical GmbH

EUDAMED last updated this device on May 6, 2026

OVU-KR-2

426035994OVULT

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: VivoSensMedical GmbH
UDI-DI code: 04260359940129
Reference / catalog number: OVU-KR-2

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Manufacturer information

Organization name: VivoSensMedical GmbH
SRN: DE-MF-000007273
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Jan 1, 2013	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04260359940129
Basic UDI-DI: 426035994OVULT
Reference / catalog number: OVU-KR-2
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: Der Kunststoffring, in den der OvulaRing-Sensor eingesetzt wird, ist ein auszutauschendes Zubehörteil mit direktem Körperkontakt. Er wird regelmäßig ersetzt.Damit erfüllt er die Definition eines Consumables (Verbrauchsmaterials) im Sinne der EMDN: ein Produktteil, das für eine begrenzte Nutzungsdauer bestimmt ist und regelmäßig ersetzt werden muss.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12080285GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - CONSUMABLES

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

OVU-APP426035994OVUAPPMLOn the market OVU-BS-2.4426035994OVULTOn the market OVU-SW 5.x.xB-04260359940136On 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.