Laser Filter Slide: 190-400NM=OD5+, 808-840NM=OD4+, >840-950NM=OD5+, >950-1080NM M 1047LFYG3
Ref M 1047LFYG3Model Global Surgical Operating Microscope System
Active
CE MDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number081004025GSOMSWD 00810040251207 | Date29 Sep 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00810040251207 | Date20 Sep 2021 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Laser Filter Slide: 190-400NM=OD5+, 808-840NM=OD4+, >840-950NM=OD5+, >950-1080NM
- Generic Name
- General-purpose surgical microscope
- Model / Reference
- M 1047LFYG3, Global Surgical Operating Microscope System
- Primary DI / UDI-DI
- 00810040251207
- Basic UDI-DI
- 081004025GSOMSWD
- Direct Marketing DI
- 00810040251207
- FDA Product Code
- EPT
- EMDN Code
- Z12011101 Operative microscopes
- GMDN Term
- General-purpose surgical microscope
- Device Class
- Class I
- Regulation Number
- 878.4700
- EU market of registration
- Netherlands
- GUDID distribution status
- In Commercial Distribution
Other devices from Global Surgical Corp.
Properties
Other properties (20)
- Sterile: No
- Single Use: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Lot / Batch Number: No
- Expiration Date: No