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Respiratory Calibration Gas

EUDAMED

Class I (EU MDR)

Ref Z03NI808EDC007Ref Z03NI798EDC000Ref OX MDGEDNUC833Ref Z04NI785EDC004

by Airgas Therapeutics LLC

Identity

Device Name
Respiratory Calibration Gas EUDAMED
Model / Reference
Z03NI808EDC007 EUDAMED
Z03NI798EDC000 EUDAMED
OX MDGEDNUC833 EUDAMED
Z04NI785EDC004 EUDAMED

Identifiers

Primary DI / UDI-DI
00819601023208 EUDAMED
00819601023215 EUDAMED
01008691023222 EUDAMED
00819601023192 EUDAMED
Basic UDI-DI
08196010201LF EUDAMED
Direct Marketing DI
00819601023208 EUDAMED
00819601023215 EUDAMED
01008691023222 EUDAMED
00819601023192 EUDAMED
EMDN Code
R020108 RESPIRATORY GAS MONITORING AND SAMPLING CIRCUITS AND KITS EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Italy EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Respiratory Calibration Gas by Airgas Therapeutics — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
US-MF-000032722
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (4)

  • EUDAMED 8409047a-1b2b-4d93-a4b5-84f0a83fc2c5 61 fields · synced Jul 22, 2026
  • EUDAMED 64757516-3b9f-4347-ad92-6222ed28462f 61 fields · synced May 16, 2026
  • EUDAMED 724d1515-0c25-4fd3-96c7-6770948b9d44 61 fields · synced May 16, 2026
  • EUDAMED 02df150e-0af2-4543-a3f1-f7d7acf4ca92 61 fields · synced May 17, 2026