Identity
- Device Name
- Surgical Microscope EUDAMED
- Model / Reference
- iSee 9000 EUDAMEDiSee pro EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975384334161 EUDAMED
- Basic UDI-DI
- 697538433001MC EUDAMED
- EMDN Code
- Z12011101 OPERATIVE MICROSCOPES 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
Surgical Microscope by Guilin Kevin Peter Technology 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 | 697538433001MC | Class I | Active |
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Manufacturer
- Manufacturer
- Guilin Kevin Peter Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000022934
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 9d506868-d772-44b8-9617-b69664dc0ed3 61 fields · synced Jul 10, 2026