Identity
- Trade Name
- Operating Microscope EUDAMED
- Device Name
- Operating Microscope EUDAMED
- Model / Reference
- E-Optix GT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974456212345 EUDAMED
- Basic UDI-DI
- 697445621E-OptixGTLS EUDAMED
- EMDN Code
- Z12011101 OPERATIVE MICROSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Operating Microscope by Foshan CICADA Dental Instrument Co., 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 | 697445621E-OptixGTLS | Class I | Active |
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Manufacturer
- Manufacturer
- Foshan Cicada Dental Instrument Co., Ltd
- EUDAMED SRN
- CN-MF-000001167
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED c45be090-9419-4650-b3a3-b1ba3422810b 61 fields · synced Jul 12, 2026