Identity
- Trade Name
- Ventilator Device EUDAMED
- Device Name
- Ventilator Device EUDAMED
- Model / Reference
- OKM IBS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08680992312279 EUDAMED08680992312811 EUDAMED08680992312798 EUDAMED
- Basic UDI-DI
- B-08680992312279 EUDAMEDB-08680992312811 EUDAMEDB-08680992312798 EUDAMED
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Pulmonary function analysis system, adult
Ventilator Device by Okuman Medikal Sistemler Anonim Sirketi — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08680992312279 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Okuman Medikal Sistemler Anonim Sirketi
- EUDAMED SRN
- TR-MF-000015167
Sources (3)
- EUDAMED e68ca393-f282-45de-b4ae-09b00c522793 61 fields · synced Jul 27, 2026
- EUDAMED f8469ec8-f260-4ab0-ae99-cb6626b0a376 61 fields · synced May 19, 2026
- EUDAMED 0444671a-c857-4f35-ae7e-38f99d484d7c 61 fields · synced May 19, 2026