Surgical Microscope
by Guilin Kevin Peter Technology Co., Ltd.
Ref 06975384330019Model iSee 9000
Surgical Microscope (06975384330019) is a dental surgical microscope (EU MDR Class I; FDA Class I; FDA product code EPT, Microscope, Surgical) made by Guilin Kevin Peter Technology Co., Ltd., registered in EUDAMED on 22 Sep 2024 (Basic UDI-DI 697538433001MC) and listed in FDA GUDID since 24 Oct 2023 (UDI-DI 06975384330019), active as of 22 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number697538433001MC 06975384330019 | Date22 Sep 2024 | StatusActive |
| United States | GUDID listing GUDID | Number06975384330019 | Date24 Oct 2023 | StatusListed |
Official records
- EUDAMED public site 697538433001MC
- AccessGUDID record 06975384330019
Across registries
- EUDAMED Basic UDI-DI 697538433001MC registered 22 Sep 2024 Active
- FDA GUDID UDI-DI 06975384330019 listed 24 Oct 2023 Listed
Timeline
- Listed FDA GUDID 06975384330019
- Registered EUDAMED 697538433001MC
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Surgical Microscope EUDAMEDKp GUDID
- Generic name
- Dental surgical microscope
- Model / reference
- iSee 9000, 06975384330019
- Primary DI / UDI-DI
- 06975384330019
- Basic UDI-DI
- 697538433001MC
- Direct marketing DI
- 06975384330019
- FDA product code
- EPT
- EMDN code
- Z12011101 Operative microscopes
- GMDN term
- Dental surgical microscope
- Device class
- Class I
- Regulation number
- 878.4700
- System or procedure pack
- System which is a device in itself
- EU registration type
- Standard device
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
Manufacturer details
- EUDAMED SRN
- CN-MF-000022934
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
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