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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

2003 — Class I MDD by Metis Healthcare s.r.l.

MD Atlas
Metis Healthcare s.r.l.

EUDAMED last updated this device on Oct 30, 2023

2003

B-20039K

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Metis Healthcare s.r.l.
UDI-DI code: D-20039K
Reference / catalog number: 2003

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View device family (Basic UDI)

Manufacturer information

Organization name: Metis Healthcare s.r.l.
SRN: IT-MF-000007609
Manufacturer status: Active

Critical warnings

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

CW011
Hypersensitivity to one of the components or similar substances.

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Market distribution

Primary placement in Italy; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: D-20039K
Basic UDI-DI: B-20039K
Reference / catalog number: 2003
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: Golabact® MED Gola spray is designed to protect the oral mucosa by means of film-forming activity, hence limiting the adhesion of pathogenic bacteria and relieving sore due to irritated throat
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-20039K

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.

V9017ORAL ADMINISTRATION PREPARATIONS NOT INCLUDED IN OTHER CLASSES

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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Related devices

0418B-0418A6On the market

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.