Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Partners Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

84EN-17 — Class I MDD by GLOBAL PHARMA CM S.A

MD Atlas
GLOBAL PHARMA CM S.A

EUDAMED last updated this device on May 12, 2025

84EN-17

B-84EN-17CU

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-17CU
Reference / catalog number: 84EN-17

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

View device family (Basic UDI)

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.

EasyUDICompliance engine

Sponsored

Your devices, UDI-compliant — without drowning in regulation

EUDAMED-ready· UDI-enriched

Basic UDIUDI-DIUDI-PIAttributeDocument

Print-ready label

From your product file — no manual entry

Exclusive to MD Atlas usersClaim my −20% discount

by Made In Tracker

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-17CU
Basic UDI-DI: B-84EN-17CU
Reference / catalog number: 84EN-17
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: 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-17CU

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

Become a partner of MD Atlas

Related devices

B-122EN-34JB-128EN-26JOn the market 85EN-5B-85EN-5YLOn the market B-84PL-8YFB-84EN-8YFOn the market AftiBLOCK® NANO sprayB-131EN-34LOn the market 88EN-6B-88EN-6ZPOn 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.