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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

0258 — Class IIb MDD by NewWaterMeaning s.r.o.

MD Atlas
NewWaterMeaning s.r.o.

EUDAMED last updated this device on Oct 10, 2025

0258

B-08595584500111

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: NewWaterMeaning s.r.o.
UDI-DI code: 08595584500111
Reference / catalog number: 0258

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Manufacturer information

Organization name: NewWaterMeaning s.r.o.
SRN: CZ-MF-000006576
Manufacturer status: Active

Market distribution

Primary placement in Czechia; available across 2 countries total.

Country	On market since	Until
CzechiaPrimary placement	Jan 1, 2015	Still on market
Slovakia	Jan 1, 2015	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08595584500111
Basic UDI-DI: B-08595584500111
Reference / catalog number: 0258
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 250 MU24

EMDN nomenclature code(s)

M04041503DRESSINGS IN SOLUTIONS, EMULSIONS, GELS, POWDERS WITH SYNTHETIC COMPONENTS

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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

0272B-08595584500074On the market 0715B-08595584500173On the market 0241B-08595584500012On the market 0234B-08595584500081On the market 0760B-08595584500166On 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.