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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

PREMENO Ovules Vaginaux — Class IIb MDR by LO.LI. PHARMA S.r.l.

MD Atlas
LO.LI. PHARMA S.r.l.

EUDAMED last updated this device on Nov 13, 2025

PREMENO Ovules Vaginaux

805848125SantesOvuliWF

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: LO.LI. PHARMA S.r.l.
UDI-DI code: 08058481250973
Reference / catalog number: PREMENO Ovules Vaginaux

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Manufacturer information

Organization name: LO.LI. PHARMA S.r.l.
SRN: IT-MF-000023734
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement		Still on market

Device identification

Trade name: PREMENO Ovules Vaginaux
UDI-DI code: 08058481250973
Basic UDI-DI: 805848125SantesOvuliWF
Reference / catalog number: PREMENO Ovules Vaginaux
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

U0899GYNAECOLOGICAL DEVICES - 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

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Certificates

Certificate health across this manufacturer's portfolio.

IT339826Issued
Quality management systemNotified body: 1370Expiry: Apr 15, 2029