Disposable 3 Ply Earloop 3D Medical Face Mask
Ref Pack UnitModel 3DBEAR，3DMASK，3DMASK Ultra， 3DMEOW，3DMASK Kids，ClassicMask，PremiumMask， RoyalMask，RegalMask
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 | Number489711514FACEMASKUF | Date12 Jun 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- Withdrawn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 3 Ply Earloop 3D Medical Face Mask
- Model / Reference
- 3DBEAR，3DMASK，3DMASK Ultra， 3DMEOW，3DMASK Kids，ClassicMask，PremiumMask， RoyalMask，RegalMask, Pack Unit
- Primary DI / UDI-DI
- 04897115141157, 04897115141065, 04897115141454, 04897115141430, 04897115141140
- Basic UDI-DI
- 489711514FACEMASKUF
- Direct Marketing DI
- 0489711514115704897115141065048971151414540489711514143004897115141140
- EMDN Code
- T020604 Medical use face masks, type II and iir
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- HK-MF-000042511
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Savewo Limited
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