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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

08430308131861 — Class IIa MDD by Polichem SA,…

MD Atlas
Polichem SA, Lussemburgo, succursale di Mendrisio

EUDAMED last updated this device on Jan 11, 2024

08430308131861

B-08430308131861

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: 08430308131861
Reference / catalog number: 08430308131861

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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 if you are allergic (hypersensitive) to any of the components of Betalfatrus®. WARNINGS For dermal use. Do not ingest. Inflammable. Close the bottle immediately after use. Keep out of the reach and sight of children. The device is intended for an individual use and must not be shared with other people.

Market distribution

Primary placement in Portugal; available across 1 country total.

Country	On market since	Until
PortugalPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08430308131861
Basic UDI-DI: B-08430308131861
Reference / catalog number: 08430308131861
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)

V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - 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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

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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.