AlphaScope™
by Gimmi GmbH United States EUDAMED
Ref E.8290.11 RE
EMDN Z12029009
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-04049047202554 | Date11 Sep 2026 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/MDD Expiring (legacy directive)
Specification
- Device Name
- Rexflat Alphascope Ii Laparoscope
- Model / Reference
- E.8290.11 RE
- Primary DI / UDI-DI
- 04049047202554
- Basic UDI-DI
- B-04049047202554
- EMDN Code
- Z12029009 Laparoscopes
- Device Class
- Class IIa
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000005445
Other devices from Gimmi GmbH
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- Sterile: No
- Implantable: 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
Sources (1)
- EUDAMED 04049047202554|B-04049047202554