Stethoscope
by Taihu Huamei Medical Equipment Co., Ltd
Ref HM-110Model HM-110,HM-120,HM-200,HM-200ZB,HM-250,HM-250P,HM-250G,HM-400,HM-421,HM-421P,HM-450,HM-450P,HM-9260
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 | Number697140508stethoscope92 06971405080017 | Date7 Jul 2023 | 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- Withdrawn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
- Stethoscope
- Model / Reference
- HM-110, HM-120, HM-200, HM-200ZB, HM-250, HM-250P, HM-250G, HM-400, HM-421, HM-421P, HM-450, HM-450P, HM-9260
- Primary DI / UDI-DI
- 06971405080017
- Basic UDI-DI
- 697140508stethoscope92
- EMDN Code
- C9005 Phonendoscopes and stethoscopes
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000029363
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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