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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

BIGUANELLE — Class IIb MDR by LO.LI. PHARMA S.r.l.

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

EUDAMED last updated this device on Mar 17, 2025

BIGUANELLE

805848125MONOGINsoluzNX

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: 08058481250171
Reference / catalog number: BIGUANELLE

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Manufacturer information

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

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Certificates

Certificate health across this manufacturer's portfolio.

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

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Bulgaria; available across 2 countries total.

Country	On market since	Until
BulgariaPrimary placement		Still on market
Romania		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08058481250171
Basic UDI-DI: 805848125MONOGINsoluzNX
Reference / catalog number: BIGUANELLE
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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