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Ai5000
EUDAMEDClass I (EU MDR)
Ref AI5000Model AI Anaesthesia frames and -holders
by Lojer Oy
Identity
- Trade Name
- AI5000 EUDAMED
- Model / Reference
- AI Anaesthesia frames and -holders EUDAMEDAI5000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06430021931092 EUDAMED
- Basic UDI-DI
- 643002193OTA0003Y6 EUDAMED
- Direct Marketing DI
- 06430021931092 EUDAMED
- EMDN Code
- T020199 SURGICAL DRAPES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland 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
Ai5000 by Lojer Oy — 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 | 643002193OTA0003Y6 | Class I | Active |
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Manufacturer
- Manufacturer
- Lojer Oy
- EUDAMED SRN
- FI-MF-000001639
Sources (1)
- EUDAMED 2ce9e3d3-3c4b-4500-af19-5005faa67025 61 fields · synced Jul 16, 2026