← Back to catalogue
Oxymat
EUDAMEDClass IIb (EU MDR)
Ref PSA Oxygen generator O60Model PSA Oxygen generator
Identity
- Trade Name
- OXYMAT EUDAMED
- Device Name
- PSA Oxygen generator EUDAMED
- Model / Reference
- PSA Oxygen generator EUDAMEDPSA Oxygen generator O60 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08588004120808 EUDAMED
- Basic UDI-DI
- 858800412000medical25 EUDAMED
- Direct Marketing DI
- 08588004120808 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
Similar devices
Also classified as Pulmonary function analysis system, adult.
- Volume Calibration Syringe — HANS RUDOLPH, INC. · Class I
- VISCOFLU — PHARMA LINE Srl · Class IIb
- Volume Calibration Syringe — HANS RUDOLPH, INC. · Class I
- CUSTOM PACK FOR NON-INVASIVE VENTILATION — Intersurgical SpA · Class IIa
- Vyaire — Jaeger Medical GmbH · Class II
- AEROCHAMBER PLUS FLOW-VU — TRUDELL MEDICAL INTERNATIONAL · Class I
- Shape II System Refurbished — Shape Medical Systems, Inc. · Class II
- CUSTOM PACK FOR NON-INVASIVE VENTILATION — Intersurgical SpA · Class IIa
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ACG Air & Gas Solutions SK s.r.o.
- EUDAMED SRN
- SK-MF-000019263
Sources (1)
- EUDAMED 2c6de64a-7f20-44af-b6d5-63c080d1f07b 61 fields · synced Jun 18, 2026