Identity
- Trade Name
- Explore 12 EUDAMED
- Device Name
- Explore Handheld Electronic Magnifier EUDAMED
- Model / Reference
- Electronic Magnifiers EUDAMEDNOM-500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18306110000824 EUDAMED
- Basic UDI-DI
- 83061100003JD EUDAMED
- Direct Marketing DI
- 18306110000824 EUDAMED
- EMDN Code
- Y210603 VIDEO MAGNIFIERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Explore 12 by Technologies HumanWare Inc. — 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 | 83061100003JD | Class I | Active |
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Manufacturer
- Manufacturer
- Technologies HumanWare Inc.
- EUDAMED SRN
- CA-MF-000022852
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (1)
- EUDAMED c0801dbe-910c-40ee-888a-320c05c14bd7 61 fields · synced Jul 26, 2026