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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

MIRAGYN — Class IIa MDD by USP - UNION OF…

MD Atlas
USP - UNION OF PHARMACEUTICAL SCIENCES S.r.l.

EUDAMED last updated this device on Jan 22, 2025

MIRAGYN

B-08032685282107

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: USP - UNION OF PHARMACEUTICAL SCIENCES S.r.l.
UDI-DI code: 08032685282107
Reference / catalog number: MIRAGYN

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Manufacturer information

Organization name: USP - UNION OF PHARMACEUTICAL SCIENCES S.r.l.
SRN: IT-MF-000041894
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08032685282107
Basic UDI-DI: B-08032685282107
Reference / catalog number: MIRAGYN
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC 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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Related devices

FIORA ScheidentrockenheitB-08032685280103On the market HYLO SPRAYB-09088886002951On 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.