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Respiratory Calibration Gas
EUDAMEDClass I (EU MDR)
Ref Z03NI808EDC007Ref Z03NI798EDC000Ref OX MDGEDNUC833Ref Z04NI785EDC004
Identity
- Device Name
- Respiratory Calibration Gas EUDAMED
- Model / Reference
- Z03NI808EDC007 EUDAMEDZ03NI798EDC000 EUDAMEDOX MDGEDNUC833 EUDAMEDZ04NI785EDC004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00819601023208 EUDAMED00819601023215 EUDAMED01008691023222 EUDAMED00819601023192 EUDAMED
- Basic UDI-DI
- 08196010201LF EUDAMED
- Direct Marketing DI
- 00819601023208 EUDAMED00819601023215 EUDAMED01008691023222 EUDAMED00819601023192 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08196010201LF | Class I | Active |
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Manufacturer
- Manufacturer
- Airgas Therapeutics LLC
- 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