Identity
- Trade Name
- Extra 818 EUDAMED
- Device Name
- Extra EUDAMED
- Model / Reference
- 818 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290016727128 EUDAMED
- Basic UDI-DI
- 7290016727IPLC3Z EUDAMED
- Direct Marketing DI
- 07290016727128 EUDAMED
- EMDN Code
- Z12040201,Z12040202 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
Extra 818 by Active Optical Systems Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 7290016727IPLC3Z | Class I | Active |
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Manufacturer
- Manufacturer
- Active Optical Systems Ltd
- EUDAMED SRN
- IL-MF-000024754
- Authorised Representative
- QS MEDICAL DEVICE REGISTRATION LTD CY-AR-000024665
Sources (1)
- EUDAMED 426ee561-aeee-45cb-8e5b-3b152004b3f4 61 fields · synced Jun 18, 2026