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Surgical Microscope
EUDAMEDFDA UDIClass I (EU MDR)
Ref 06975384330019Model iSee 9000
Identity
- Trade Name
- Surgical Microscope EUDAMEDKP FDA UDI
- Generic Name
- Dental surgical microscope FDA UDI
- Device Name
- Surgical Microscope EUDAMEDiSee 9000 surgical microscope is mainly used for microsurgery and meticulous examination. FDA UDI
- Model / Reference
- iSee 9000 EUDAMEDFDA UDI06975384330019 EUDAMED
- Description
- iSee 9000 surgical microscope is mainly used for microsurgery and meticulous examination. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975384330019 EUDAMEDFDA UDI
- Basic UDI-DI
- 697538433001MC EUDAMED
- Direct Marketing DI
- 06975384330019 EUDAMED
- FDA Product Code
- EPT FDA UDI
- EMDN Code
- Z12011101 OPERATIVE MICROSCOPES EUDAMED
- GMDN Term
- Dental surgical microscope FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4700 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Surgical Microscope by Guilin Kevin Peter Technology Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697538433001MC | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 (2)
- EUDAMED 0d2e97f1-c2c7-438e-9e3a-49ae08fb1c68 61 fields · synced Jul 28, 2026
- FDA UDI 8bc5db35-6699-4d94-96f5-a5d5a960a24a 33 fields · synced May 30, 2026