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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

Gynaedron — Class IIb MDR by HÄLSA Pharma GmbH

MD Atlas
HÄLSA Pharma GmbH

EUDAMED last updated this device on May 27, 2026

Gynaedron

42517781MD368DF

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: HÄLSA Pharma GmbH
UDI-DI code: 04251778109457
Reference / catalog number: FRT00202

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View device family (Basic UDI)

Manufacturer information

Organization name: HÄLSA Pharma GmbH
SRN: DE-MF-000007407
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: Gynaedron
UDI-DI code: 04251778109457
Basic UDI-DI: 42517781MD368DF
Reference / catalog number: FRT00202
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

UDI-DI DataMatrix

Encoded

(01)04251778109457

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

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

U0803VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETS

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

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.