Disposable 3 Ply Earloop 3D Medical Face Mask
Ref Base 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- Withdrawn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, Base Unit
- Primary DI / UDI-DI
- 04897115142130, 04897115145896, 04897115142185, 04897115144905, 04897115149078, 04897115143465, 04897115145759, 04897115146237, 04897115142062, 04897115142178, 04897115141683, 04897115142192, 04897115143250, 04897115147715, 04897115141133, 04897115146275, 04897115142109, 04897115145827, 04897115142086, 04897115148668, 04897115142147, 04897115142116, 04897115145889, 04897115142208, 04897115142215, 04897115142253, 04897115143496, 04897115142246, 04897115149412, 04897115143342, 04897115148262, 04897115149641, 04897115142871, 04897115142239, 04897115145742, 04897115145810, 04897115142987, 04897115142277, 04897115143441, 04897115144752, 04897115149955, 04897115142079, 04897115142222, 04897115145803, 04897115143502, 04897115141447, 04897115145872, 04897115142260, 04897115149405, 04897115143458
- Basic UDI-DI
- 489711514FACEMASKUF
- Direct Marketing DI
- 04897115142130048971151458960489711514218504897115144905048971151490780489711514346504897115145759048971151462370489711514206204897115142178048971151416830489711514219204897115143250048971151477150489711514627504897115142109048971151458270489711514208604897115148668048971151421470489711514211604897115145889048971151422080489711514221504897115142253048971151434960489711514224604897115149412048971151433420489711514826204897115149641048971151428710489711514223904897115145742048971151458100489711514298704897115142277048971151434410489711514475204897115149955048971151420790489711514222204897115145803048971151435020489711514144704897115145872048971151422600489711514940504897115143458
- 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