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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

08430308132837 — Class IIa MDD by Polichem SA,…

MD Atlas
Polichem SA, Lussemburgo, succursale di Mendrisio

EUDAMED last updated this device on Jan 11, 2024

08430308132837

B-08430308132837

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Polichem SA, Lussemburgo, succursale di Mendrisio
UDI-DI code: 08430308132837
Reference / catalog number: 08430308132837

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Manufacturer information

Organization name: Polichem SA, Lussemburgo, succursale di Mendrisio
SRN: CH-MF-000025294
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW999
CONTRAINDICATIONS Do not use in case of hypersensitivity to anyone of the ingredients. Do not use vaginal contraceptives while using GYNOMUNAL. Do not use GYNOMUNAL while you are on vaginal drugs or using other a vaginal medical device. WARNINGS The device (gel and applicator) is intended for a personal use and must not be shared with other people. Use only the applicator provided in the pack. Do not use applicator if it is damaged or broken. Keep out of the sight and reach of children. Do not use disinfectants or other cleanser to wash the applicator, but use only lukewarm water. Pregnant women should not use the cannula applicator. Instead, squeeze the measured amount of gel out of the applicator onto your finger. Carefully apply the gel using your finger as far as is comfortable. This product is compatible with natural rubber latex and with polyisoprene condoms, but not with polyurethane condoms.

Market distribution

Primary placement in Germany; available across 2 countries total.

Country	On market since	Until
GermanyPrimary placement		Still on market
Austria		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08430308132837
Basic UDI-DI: B-08430308132837
Reference / catalog number: 08430308132837
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.

EMDN nomenclature code(s)

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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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.

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