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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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Woda morska hipertoniczna/Hypertonic… — 1 UDI-DI variant, MDD

MD Atlas
Gofarm Sp. z o.o. Sp. k.

Data from EUDAMED, last updated May 30, 2026

Woda morska hipertoniczna/Hypertonic sea water

B-5999565289836N2

1 UDI-DI variant

MDD [Directive 93/42/EEC on medical devices]Class IIa

Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class IIa
Manufacturer: Gofarm Sp. z o.o. Sp. k.

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Device characteristics

No device characteristics flagged

Legacy certificates

Certificate number: 1434-MDD-331/2020
Type: refdata.legacy.mdd-certificate-type.v
Notified body: POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. (1434)
Validity: Dec 31, 2028

Identity & classification

Basic UDI-DI: B-5999565289836N2
Device name: Woda morska hipertoniczna/Hypertonic sea water
Device model: 100 ml
Issuing agency: EUDAMED
Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class IIa
Version date: Oct 14, 2024

Manufacturer & authorised representative

Manufacturer

Name: Gofarm Sp. z o.o. Sp. k.
SRN: PL-MF-000003485
Country: Poland
Email: office@gofarm.pl
Phone: +48 530 103 518

Variants by status

UDI-DI variants

1 UDI-DI variant

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basicUdiUlid01JA5GXBZPXVVEMJXN6Z7ZHN40

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

ENT09D-5999565289836N2