Otoscopes
by Tonglu Sike Medical Instrument Co., Ltd. China EUDAMED
Ref EJ2001AModel EJ2001, EJ2001A, EJ2002, EJ2003, EJ2003A, EJ2004, EJ2005, EJ2006, EJ2007, EJ2008, EJ2009, EJ2010, EJ2011, EJ2012, EJ2013, EJ2014, EJ2015, EJ2016, EJ2017, EJ2018, EJ2019, EJ2020, EJ2021, EJ2022, EJ2023, EJ2024, EJ2025, EJ2026
EMDN Z12149006
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697058187EJ001EQ | Date16 Dec 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Otoscopes
- Model / Reference
- EJ2001, EJ2001A, EJ2002, EJ2003, EJ2003A, EJ2004, EJ2005, EJ2006, EJ2007, EJ2008, EJ2009, EJ2010, EJ2011, EJ2012, EJ2013, EJ2014, EJ2015, EJ2016, EJ2017, EJ2018, EJ2019, EJ2020, EJ2021, EJ2022, EJ2023, EJ2024, EJ2025, EJ2026
- Primary DI / UDI-DI
- 06975633110027
- Basic UDI-DI
- 697058187EJ001EQ
- EMDN Code
- Z12149006 Direct outpatient otoscopes
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000051027
- Authorised representative
- endodoctor GmbH DE-AR-000050606
Other devices from Tonglu Sike Medical Instrument Co., Ltd.
See all devices from Tonglu Sike Medical Instrument Co., Ltd. →
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 31135ed3-f306-4ddb-8045-3d2943d81549