Emdamed
by Xiantao Longwin Medical Products Ltd. 20 variants
Ref DN-08/EMD95815Model DN-08
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 | Number697508986LWMASK01001VT | Date2 Sep 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- Withdrawn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 Face Mask
- Model / Reference
- DN-08, DN-08/EMD95815
- Primary DI / UDI-DI
- 06975089868114, 16975089868111
- Basic UDI-DI
- 697508986LWMASK01001VT
- EMDN Code
- T020604 Medical use face masks, type II and iir
- Device Class
- Class I
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000012856
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Xiantao Longwin Medical Products Ltd.
See all devices from Xiantao Longwin Medical Products 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