Sterilization Pouches
by Hubei Guarddent Medical Technology Co., Ltd 5 variants
Ref Type IIModel Type I;Type II;Type IIR;LEVEL 1;LEVEL 2;LEVEL 3
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 | Number697565200FM001CT 06978502824575 | Date17 Mar 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- Withdrawn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
- Face Mask
- Model / Reference
- Type I, Type II, Type IIR, LEVEL 1, LEVEL 2, LEVEL 3
- Primary DI / UDI-DI
- 06978502824575
- Basic UDI-DI
- 697565200FM001CT
- EMDN Code
- Q010599 Dental instruments, single-use - other
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000028116
- Authorised representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Other devices from Hubei Guarddent Medical Technology Co., Ltd
See all devices from Hubei Guarddent Medical Technology 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