Otoscopes
by Tonglu Sike Medical Instrument Co., Ltd. 25 variants
Ref EJ2003Model 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
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697058187EJ001EQ 06975633110041 | Date16 Dec 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
- 06975633110041
- Basic UDI-DI
- 697058187EJ001EQ
- EMDN Code
- Z12149006 Direct outpatient otoscopes
- Device Class
- Class I
- EU 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
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