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Organization name
UDI-DI code
Reference / catalog number

08430308133285 — Class IIa MDD by Polichem SA,…

MD Atlas
Polichem SA, Lussemburgo, succursale di Mendrisio

EUDAMED last updated this device on Jan 11, 2024

08430308133285

B-08430308133285

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: 08430308133285
Reference / catalog number: 08430308133285

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Manufacturer information

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

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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.

Critical warnings

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

CW999
DO NOT USE VAGI-C If you are allergic (hypersensitive) to any of the components of the product. If you have or suspect to have a yeast vaginal infection (e.g. candidiasis), because the acidification of vaginal pH may promote their proliferation WARNINGS Keep out of the sight and reach of children. Do not swallow. Don't store above 30 º C . Do not use broken tablets to avoid accidental injuries during insertion VAGI-C may contain small traces of bovine milk protein.

Market distribution

Primary placement in Finland; available across 1 country total.

Country	On market since	Until
FinlandPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08430308133285
Basic UDI-DI: B-08430308133285
Reference / catalog number: 08430308133285
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

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Software identification