Identity
- Trade Name
- Defibrillator Monitor EUDAMED
- Device Name
- Defibrillator Monitor EUDAMED
- Model / Reference
- DFM 800 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08680992312774 EUDAMED08680992312781 EUDAMED08680992312262 EUDAMED
- Basic UDI-DI
- B-08680992312774 EUDAMEDB-08680992312781 EUDAMEDB-08680992312262 EUDAMED
- EMDN Code
- Z12030501 SEMI-AUTOMATIC DEFIBRILLATORS 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
Defibrillator Monitor by Okuman Medikal Sistemler Anonim Sirketi — Class IIb — CE/MDR — listed in EUDAMED — regulatory data on deviCERTS
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-08680992312774 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Okuman Medikal Sistemler Anonim Sirketi
- EUDAMED SRN
- TR-MF-000015167
Sources (3)
- EUDAMED 3432d256-a882-48cb-ba93-15c924c11c10 61 fields · synced Oct 7, 2026
- EUDAMED 8dc85b5c-0325-491d-a44e-eaae17b8356f 61 fields · synced May 18, 2026
- EUDAMED 8810d5fb-4d66-4721-9eff-31201fa73676 61 fields · synced May 18, 2026