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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

ADVANCIS® Nasocare® — Class III MDD by LABIALFARMA –…

MD Atlas
LABIALFARMA – LABORATÓRIO DE PRODUTOS FARMACÊUTICOS E NUTRACÊUTICOS, S.A.

EUDAMED last updated this device on Sep 20, 2023

ADVANCIS® Nasocare®

B-PTMF00000355114536AJU

On the marketClass III

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: LABIALFARMA – LABORATÓRIO DE PRODUTOS FARMACÊUTICOS E NUTRACÊUTICOS, S.A.
UDI-DI code: D-PTMF00000355114536AJU
Reference / catalog number: 8878/14536A

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View device family (Basic UDI)

Manufacturer information

Organization name: LABIALFARMA – LABORATÓRIO DE PRODUTOS FARMACÊUTICOS E NUTRACÊUTICOS, S.A.
SRN: PT-MF-000003551
Manufacturer status: Active

Critical warnings

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

CW999
Contraindications and Precautions of Use: Do not use in children under 2 years of age. It should be used under adult supervision in children up to 12 years of age. This product should not be used in patients with hemophilia and mechanical obstruction ileus. Do not use in case of hypersensitivity to Dexpanthenol or any of the components. If you notice sensitivity to the product, you should stop using it and consult a doctor. This medical device contains benzalkonium chloride as preservative (0.1 mg/ml) which can cause tumefaction (swelling) of the nasal mucosa, especially if used for long periods of time. If you suspect that you are experiencing this reaction (persistent nasal congestion), you should stop using the product and consult with your doctor. The duration of administration should not exceed 5 days, after which, if symptoms persist, a doctor should be consulted. This product must not be used for a prolonged period of time. If symptoms persist or worsen, consult your doctor or pharmacist. If you are pregnant or breastfeeding, consult your doctor before using this medical device. The product should not be used after the date indicated on the packaging. After the first application, do not use the product for more than 6 months.

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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: ADVANCIS® Nasocare®
UDI-DI code: D-PTMF00000355114536AJU
Basic UDI-DI: B-PTMF00000355114536AJU
Reference / catalog number: 8878/14536A
Issuing entity: EUDAMED

Classification

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

Device details

Quantity: 1
Additional product description: Isotonic solution with 5% dexpanthenol which provides a decongestant cleaning action and a moisturizing effect on the nasal mucosa, improving its regeneration ability and physiological balance in discomfort situations.
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

D-PTMF00000355114536AJU

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.