Identity
- Trade Name
- CLEAN AIR® EUDAMED
- Device Name
- Clean Air EUDAMED
- Model / Reference
- ORS-VAC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260665921553 EUDAMED
- Basic UDI-DI
- 426066592ORS-CAEJ EUDAMED
- Direct Marketing DI
- 04260665921553 EUDAMED
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Category: Pulmonary function analysis system, adult
Clean Air® by Technologie Institut Medizin GmbH (TIM) — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 426066592ORS-CAEJ | Class I | Active |
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Manufacturer
- Manufacturer
- Technologie Institut Medizin GmbH (TIM)
- EUDAMED SRN
- DE-MF-000018722
Sources (1)
- EUDAMED 9d537f83-5dd0-49b6-90b3-937d0d12aaf9 61 fields · synced Jul 9, 2026