ZEEMAN reading glasses
by Wenzhou Sunrise Industrial and Trading Co., Ltd 25 variants
Ref RDR05189-005 +3.0, RDR05189-005 +1.5, RDR03628-004 +3.0, RDR05189-005 +2.5, RDR03628-004 +1.0, RDR04838-005 +2.5, RDR05189-004 +2.0, RDR04838-006 +3.0, RDR04838-005 +2.0, RDR03628-006 +3.5, RDR03628-006 +3.0, RDR03717-011 +3.0, RDR03717-006 +3.0, RDR04838-005 +1.5, RDR03717-006 +1.5, RDR03717-006 +2.5, RDR03717-011 +1.5, RDR03628-006 +2.5, RDR04838-006 +1.0
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 | Number697767960REGLY4 | Date26 Jul 2024 | 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- Withdrawn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
- Reading glasses
- Model / Reference
- RDR05189-005 +3.0, RDR05189-005 +1.5, RDR03628-004 +3.0, RDR05189-005 +2.5, RDR03628-004 +1.0, RDR04838-005 +2.5, RDR05189-004 +2.0, RDR04838-006 +3.0, RDR04838-005 +2.0, RDR03628-006 +3.5, RDR03628-006 +3.0, RDR03717-011 +3.0, RDR03717-006 +3.0, RDR04838-005 +1.5, RDR03717-006 +1.5, RDR03717-006 +2.5, RDR03717-011 +1.5, RDR03628-006 +2.5, RDR04838-006 +1.0
- Primary DI / UDI-DI
- 06977679602368, 06977679602337, 06977679600289, 06977679602351, 06977679603181, 06977679600319, 06977679602306, 06977679600340, 06977679600302, 06977679600258, 06977679600241, 06977679600401, 06977679600371, 06977679600296, 06977679600074, 06977679600364, 06977679600081, 06977679600234, 06977679600050
- Basic UDI-DI
- 697767960REGLY4
- Direct Marketing DI
- 06977679602368069776796023370697767960028906977679602351069776796031810697767960031906977679602306069776796003400697767960030206977679600258069776796002410697767960040106977679600371069776796002960697767960007406977679600364069776796000810697767960023406977679600050
- EMDN Code
- Q0210030102 Ready to wear plastic spectacles with organic lenses
- Device Class
- Class I
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000043059
- Authorised representative
- Humiss Beratung GmbH DE-AR-000023447
Other devices from Wenzhou Sunrise Industrial and Trading Co., Ltd
See all devices from Wenzhou Sunrise Industrial and Trading 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