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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

84EN-5 — Class I MDD by GLOBAL PHARMA CM S.A

MD Atlas
GLOBAL PHARMA CM S.A

EUDAMED last updated this device on Feb 22, 2024

84EN-5

B-84EN-5Y9

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: GLOBAL PHARMA CM S.A
UDI-DI code: D-84EN-5Y9
Reference / catalog number: 84EN-5

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View device family (Basic UDI)

Manufacturer information

Organization name: GLOBAL PHARMA CM S.A
SRN: PL-MF-000034662
Manufacturer status: Active

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Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Poland; available across 1 country total.

Placed on the market in Poland; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: D-84EN-5Y9
Basic UDI-DI: B-84EN-5Y9
Reference / catalog number: 84EN-5
Issuing entity: EUDAMED

Classification

Risk category: Class I
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Wyrób medyczny może być stosowany wspomagająco w profilaktyce i wsparciu w leczeniu objawów nieżytu nosa oraz kataru siennego,codziennej higienie nosa,nawilżaniu wysuszonej błony śluzowej nosa,łagodząco w czasie podrażnienia śluzówki nosa w stanach infekcji i alergii.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 100 MU03

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

D-84EN-5Y9

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

EMDN nomenclature code(s)

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

Q030103NASAL IRRIGATION SOLUTIONS

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.