← Back to catalogue
Loupe/Powered Loupe
EUDAMEDClass I (EU MDR)
Ref Plano OmniOptic Frame Dragonfly Frame
Identity
- Device Name
- Loupe/Powered Loupe EUDAMED
- Model / Reference
- Plano OmniOptic Frame Dragonfly Frame EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850036373346 EUDAMED
- Basic UDI-DI
- 06153753000002EP EUDAMED
- EMDN Code
- Z129004 LIGHT SOURCES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Loupe/Powered Loupe by Metrex Research — 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 | 06153753000002EP | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Metrex Research LLC.
- EUDAMED SRN
- US-MF-000043710
- Authorised Representative
- KERR ITALIA SRL IT-AR-000007600
Sources (1)
- EUDAMED 630f1163-ba42-4e34-89aa-cd376dd56d5c 61 fields · synced Jul 17, 2026