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Explore 8
EUDAMEDClass I (EU MDR)
Ref NOM-400 - FGEX-1025Model Electronic MagnifiersRef NOM-400
Identity
- Trade Name
- Explore 8 EUDAMED
- Device Name
- Explore Handheld Electronic Magnifier EUDAMED
- Model / Reference
- Electronic Magnifiers EUDAMEDNOM-400 - FGEX-1025 EUDAMEDNOM-400 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18306110001203 EUDAMED18306110000480 EUDAMED
- Basic UDI-DI
- 83061100003JD EUDAMED
- Direct Marketing DI
- 18306110001203 EUDAMED18306110000480 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 8 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 (2)
- EUDAMED f90460bd-f9f2-4329-bb8d-40f69761c739 61 fields · synced Jul 26, 2026
- EUDAMED 31b6d988-6434-499a-a9d4-0142ff239f8c 61 fields · synced May 17, 2026