Grieshaber
by Alcon Laboratories, Inc. United States EUDAMEDGUDID
Ref 725.03
Product code HQCEMDN Z12120285
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number038065GMN000162H6 | Date17 Sep 2025 | StatusActive |
| United States | GUDID listing GUDID | Number07612717071391 | Date24 Sep 2016 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Grieshaber EUDAMEDAlcon Grieshaber GUDID
- Generic Name
- Ophthalmic surgical instrument handle, pneumatic
- Device Name
- Pneumatic Handpiece DSP
- Model / Reference
- 725.03
- Primary DI / UDI-DI
- 07612717071391
- Basic UDI-DI
- 038065GMN000162H6
- FDA Product Code
- HQC
- EMDN Code
- Z12120285 Therapeutic and surgical ophtholmological treatments instruments - consumables
- GMDN Term
- Ophthalmic surgical instrument handle, pneumatic
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 886.4670
- Market of Registration
- Belgium
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa | Class II |
Manufacturer details
- EUDAMED SRN
- US-MF-000016248
- Authorised representative
- Alcon Laboratories Belgium BE-AR-000014721
Other devices from Alcon Laboratories, Inc.
Properties & raw data
Show properties, registry sources and raw records
Other properties (18)
- 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
- Premarket Exempt: No
- Serial Number: No
Sources (2)
- EUDAMED e109f49b-7bf1-4649-b586-bdc960b28e14
- FDA UDI 57561764-1862-4a73-a8aa-b622ba286b42