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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

regulators-dispensers — Class IIb MDD by MetalERG Spółka z…

MD Atlas
MetalERG Spółka z ograniczoną odpowiedzialnością

EUDAMED last updated this device on May 8, 2026

regulators-dispensers

B-05905496420101

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: MetalERG Spółka z ograniczoną odpowiedzialnością
UDI-DI code: 05905496420101
Reference / catalog number: R-100

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View device family (Basic UDI)

Manufacturer information

Organization name: MetalERG Spółka z ograniczoną odpowiedzialnością
SRN: PL-MF-000034757
Manufacturer status: Active

Related devices

ReducerB-05905496420019On the market Z-100.2.2.PB-05905496420002On 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.

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW030
Dozownik-Regulator powinien być obsługiwany przez osoby uprawnione i po zapoznaniu się z instrukcją obsługi.
CW020
Reduktor nie podlega sterylizacji

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Market distribution

Primary placement in Poland; available across 1 country total.

Country	On market since	Until
PolandPrimary placement	Sep 25, 2007	Dec 31, 2028

Device identification

Trade name: regulators-dispensers
UDI-DI code: 05905496420101
Basic UDI-DI: B-05905496420101
Reference / catalog number: R-100
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: Dozownik-Regulator do dystrybucji tlenu medycznego
Additional information URL: https://metalerg.pl/wp-content/uploads/2025/04/Instrukcja-Dozownik-Regulatora-R-100_R-100N-v24.pdf
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

Encoded

(01)05905496420101

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Z120309MEDICAL/MEDICINAL GAS PIPELINE SYSTEMS AND RELATED ACCESSORIES

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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