AlphaScope™
by Gimmi GmbH United States EUDAMED
Ref E.8187.11
EMDN Z12149006
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number4049047ZAO10AFA27DROZJ | Date15 Jul 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Laryngoscope, Otoscope and Accessories
- Model / Reference
- E.8187.11
- Primary DI / UDI-DI
- 04049047042358
- Basic UDI-DI
- 4049047ZAO10AFA27DROZJ
- Direct Marketing DI
- 04049047042358
- EMDN Code
- Z12149006 Direct outpatient otoscopes
- Device Class
- Class I
- 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 (13)
- Sterile: 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
Sources (1)
- EUDAMED 04049047042358|4049047ZAO10AFA27DROZJ