Disposable medical mask
by Zhejiang Changdi Medical Co., Ltd. 3 variants
Ref 17.5×9.5cmModel 18*9CM，17.5*9.5CM,15*9CM,14*8CM,19.5*8.5CM,15.5*10.5CM,customized size
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 | Number697736995DMM001U6 06977369950663 | Date9 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- Withdrawn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 medical mask
- Model / Reference
- 18*9CM，17.5*9.5CM, 15*9CM, 14*8CM, 19.5*8.5CM, 15.5*10.5CM, customized size, 17.5×9.5cm
- Primary DI / UDI-DI
- 06977369950663
- Basic UDI-DI
- 697736995DMM001U6
- EMDN Code
- T020604 Medical use face masks, type II and iir
- Device Class
- Class I
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000027010
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Zhejiang Changdi Medical 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