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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

128EN-3 — Class I MDD by GLOBAL PHARMA CM S.A

MD Atlas
GLOBAL PHARMA CM S.A

EUDAMED last updated this device on Sep 9, 2025

128EN-3

B-128EN-36L

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-128EN-36L
Reference / catalog number: 128EN-3

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Manufacturer information

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

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Czechia; available across 2 countries total.

Country	On market since	Until
CzechiaPrimary placement	Sep 9, 2025	Dec 31, 2028
Slovakia	Sep 9, 2025	Dec 31, 2028

Device identification

Trade name: not provided
UDI-DI code: D-128EN-36L
Basic UDI-DI: B-128EN-36L
Reference / catalog number: 128EN-3
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: The medical device can be used supportively in: regeneration of the nasal mucosa, formation of protective film on the surface of nasal mucosa, which protects it from the harmful effects of external factors, in conditions of rhinitis and sinusitis.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 30 MU03

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

D-128EN-36L

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.

Q030199NASOPHARYNGEAL DEVICES - 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

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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.