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Oxymat
EUDAMEDClass IIb (EU MDR)
Ref PSA Oxygen generator O20Model PSA Oxygen generatorRef PSA Oxygen generator O280Ref PSA Oxygen generator O10Ref PSA Oxygen generator O40
Identity
- Trade Name
- OXYMAT EUDAMED
- Device Name
- PSA Oxygen generator EUDAMED
- Model / Reference
- PSA Oxygen generator EUDAMEDPSA Oxygen generator O20 EUDAMEDPSA Oxygen generator O280 EUDAMEDPSA Oxygen generator O10 EUDAMEDPSA Oxygen generator O40 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08588004120785 EUDAMED08588004120846 EUDAMED08588004120778 EUDAMED08588004120792 EUDAMED
- Basic UDI-DI
- 858800412000medical25 EUDAMED
- Direct Marketing DI
- 08588004120785 EUDAMED08588004120846 EUDAMED08588004120778 EUDAMED08588004120792 EUDAMED
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Denmark 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Pulmonary function analysis system, adult
Oxymat by ACG Air & Gas Solutions SK s.r.o. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Pulmonary function analysis system, adult.
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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 | 858800412000medical25 | Class IIb | Active |
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Manufacturer
- Manufacturer
- ACG Air & Gas Solutions SK s.r.o.
- EUDAMED SRN
- SK-MF-000019263
Sources (4)
- EUDAMED 7e9645a1-73f3-4400-93cb-c67a5985773e 61 fields · synced Aug 4, 2026
- EUDAMED a17f0b03-27d6-47ae-94b0-ba483965090f 61 fields · synced May 17, 2026
- EUDAMED 875f5e89-8163-4eec-a037-20c85dfde3c2 61 fields · synced May 19, 2026
- EUDAMED 0608f637-b0a9-4508-b38c-b150464d1e3a 61 fields · synced May 19, 2026