Barrier Film/Sleeves
by Wellmed Dental Medical Supply Co., Ltd 221 variants
Model HL-6563-BIORef HL-6579
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 | Number697460865HL-6563-BIOS7 06974608652135 | Date16 Sep 2025 | 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- Withdrawn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
- Barrier Film/Sleeves
- Model / Reference
- HL-6563-BIO, HL-6579
- Primary DI / UDI-DI
- 06974608652135
- Basic UDI-DI
- 697460865HL-6563-BIOS7, 697460865HL-6579J4
- EMDN Code
- T030102, T0299
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000003243
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Wellmed Dental Medical Supply Co., Ltd
See all devices from Wellmed Dental Medical Supply 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