Disposable headphone covers
by Hubei Healthwell Protective Products Co., Ltd EUDAMED
Active
Ref 2.5’’Model 2.5’’,3’’,3.5’’,4’’,4.5’’,5’’,5.5’’
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697889597DHC001X6 | Date25 Jul 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Disposable headphone covers
- Model / Reference
- 2.5’’, 3’’, 3.5’’, 4’’, 4.5’’, 5’’, 5.5’’
- Primary DI / UDI-DI
- 06978895970019
- Basic UDI-DI
- 697889597DHC001X6
- EMDN Code
- T0299 Protection drapes and garments - other
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000008988
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Hubei Healthwell Protective Products 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