Otoscope and ophthalmoscope Set
by Shanghai Bize Import and Export Co., Ltd
Ref SH-OTP100Model SH-OTP100; SH-OTP200; SH-OTP300; SH-OTP400
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697587603OAOS00142 06975876035002 | Date8 Jan 2024 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Otoscope and ophthalmoscope Set
- Model / Reference
- SH-OTP100, SH-OTP200, SH-OTP300, SH-OTP400
- Primary DI / UDI-DI
- 06975876035002
- Basic UDI-DI
- 697587603OAOS00142
- EMDN Code
- Z12021007, Z12120114
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000037405
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Shanghai Bize Import and Export Co., Ltd
See all devices from Shanghai Bize Import and Export Co., Ltd →
Properties
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