Disposable Barrier Sleeves/Covers/Film
by Snowdent Healthcare Co., Ltd
Ref C1001Model SD-6580、SD-6594、SD-6615、SD-20831、SD-20963、SD-21013、SD-20855
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 | Number697999994sleeve420B6 06979999944647 | Date20 Apr 2026 | 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- Withdrawn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
- Disposable Barrier Sleeves/Covers/Film
- Model / Reference
- SD-6580、SD-6594、SD-6615、SD-20831、SD-20963、SD-21013、SD-20855, C1001
- Primary DI / UDI-DI
- 06979999944647
- Basic UDI-DI
- 697999994sleeve420B6
- EMDN Code
- Q010599 Dental instruments, single-use - other
- Device Class
- Class I
- EU market of registration
- Sweden
Manufacturer details
- EUDAMED SRN
- CN-MF-000008775
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Snowdent Healthcare 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