Sostrene Reader
by Wenzhou Sunrise Industrial and Trading Co., Ltd 46 variants
Ref RDR04503-001 +2.5, RDR04888-000 +3.0, RDR05331-000 +1.5, RDR04888-000 +2.5, RDR05293-002 +2.0, RDR04639-001 +1.0, RDR04983-000 +1.5, RDR04837-003, RDR04475-003 +1.0, RDR04639-001 +1.5, RDR05307-005 +1.5, RDR05111-001 +2.5, RDR04837-002 +1.5, RDR05022-000 +3.0, RDR04983-000 +3.0, RDR03876-005 +2.5, RDR04363-002 +3.0, RDR04363-002 +1.5, RDR05293-002 +1.5, RDR04503-001 +1.5, RDR03623-014 +2.0, RDR04837-003 +3.0, RDR04888-000 +1.5, RDR04503-001 +1.0, RDR04888-000 +2.0, RDR05307-005 +2.5, RDR04475-003 +2.0, RDR05331-000 +3.0, RDR04837-002 +2.5, RDR03623-014 +3.0, RDR04295-002 +1.5, RDR03876-005 +1.0, RDR04295-002 +3.0, RDR04798-000 +2.5, RDR04798-000 +2.0, RDR04639-001 +2.5, RDR03623-014 +1.0, RDR04503-001 +2.0, RDR04475-002 +2.0, RDR05293-002 +3.0, RDR05024-001 +3.0, RDR05307-005 +1.0, RDR05293-002 +2.5, RDR04803-000 +1.0, RDR04983-000 +2.0, RDR04888-000 +1.0, RDR05331-000 +2.0, RDR05307-005 +2.0, RDR04803-000 +3.0, RDR04798-000 +3.0, RDR05022-000 +1.5
Active
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- Withdrawn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
- Trade Name
- Sostrene ReaderWBL Trading
- Device Name
- Reading glasses
- Model / Reference
- RDR04503-001 +2.5, RDR04888-000 +3.0, RDR05331-000 +1.5, RDR04888-000 +2.5, RDR05293-002 +2.0, RDR04639-001 +1.0, RDR04983-000 +1.5, RDR04837-003, RDR04475-003 +1.0, RDR04639-001 +1.5, RDR05307-005 +1.5, RDR05111-001 +2.5, RDR04837-002 +1.5, RDR05022-000 +3.0, RDR04983-000 +3.0, RDR03876-005 +2.5, RDR04363-002 +3.0, RDR04363-002 +1.5, RDR05293-002 +1.5, RDR04503-001 +1.5, RDR03623-014 +2.0, RDR04837-003 +3.0, RDR04888-000 +1.5, RDR04503-001 +1.0, RDR04888-000 +2.0, RDR05307-005 +2.5, RDR04475-003 +2.0, RDR05331-000 +3.0, RDR04837-002 +2.5, RDR03623-014 +3.0, RDR04295-002 +1.5, RDR03876-005 +1.0, RDR04295-002 +3.0, RDR04798-000 +2.5, RDR04798-000 +2.0, RDR04639-001 +2.5, RDR03623-014 +1.0, RDR04503-001 +2.0, RDR04475-002 +2.0, RDR05293-002 +3.0, RDR05024-001 +3.0, RDR05307-005 +1.0, RDR05293-002 +2.5, RDR04803-000 +1.0, RDR04983-000 +2.0, RDR04888-000 +1.0, RDR05331-000 +2.0, RDR05307-005 +2.0, RDR04803-000 +3.0, RDR04798-000 +3.0, RDR05022-000 +1.5
- Primary DI / UDI-DI
- 06977679600852, 06977679600500, 06977679602948, 06977679600494, 06977679603105, 06977679600173, 06977679601415, 06977679600807, 06977679600135, 06977679600715, 06977679602894, 06977679603167, 06977679600753, 06977679600623, 06977679601446, 06977679600692, 06977679601491, 06977679601460, 06977679603099, 06977679600838, 06977679601521, 06977679600821, 06977679600470, 06977679600203, 06977679600487, 06977679602917, 06977679600562, 06977679602979, 06977679600777, 06977679601545, 06977679600630, 06977679600166, 06977679600661, 06977679601637, 06977679601620, 06977679600739, 06977679601507, 06977679600845, 06977679600524, 06977679603129, 06977679603075, 06977679602887, 06977679603112, 06977679601552, 06977679601422, 06977679600111, 06977679602955, 06977679602900, 06977679601590, 06977679601644, 06977679600593
- Basic UDI-DI
- 697767960REGLY4
- Direct Marketing DI
- 069776796008520697767960050006977679602948069776796004940697767960310506977679600173069776796014150697767960080706977679600135069776796007150697767960289406977679603167069776796007530697767960062306977679601446069776796006920697767960149106977679601460069776796030990697767960083806977679601521069776796008210697767960047006977679600203069776796004870697767960291706977679600562069776796029790697767960077706977679601545069776796006300697767960016606977679600661069776796016370697767960162006977679600739069776796015070697767960084506977679600524069776796031290697767960307506977679602887069776796031120697767960155206977679601422069776796001110697767960295506977679602900069776796015900697767960164406977679600593
- EMDN Code
- Q0210030102, Q0210030101
- Device Class
- Class I
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000043059
- Authorised representative
- Humiss Beratung GmbH DE-AR-000023447
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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