WBL Trading
by Wenzhou Sunrise Industrial and Trading Co., Ltd 192 variants
Ref RDR00116SE RDR05113-000 +1.5, RDR00119SE, RDR00115SE RDR05307-006 +1.5, RDR00121SE RDR05254-000 +1.0, RDR00119SE +2.0, RDR00116SE RDR05113-000 +1.0, RDR00119SE +3.0, RDR00121SE RDR05254-000 +2.0, RDR00120SE RDR05346-002 +1.5, RDR00117SE RDR05345-002 +1.0, RDR00121SE RDR05254-000 +1.5, RDR05111-001 +3.0, RDR00115SE RDR05307-006 +2.5, RDR00116SE RDR05113-000 +3.0, RDR00115SE RDR05307-006 +2.0, RDR00120SE RDR05346-002 +2.0, RDR00120SE RDR05346-002 +3.0, RDR05156-004 +1.5/RDR00002AC-996, RDR05301-000 +3.0/RDR00002AC-994, RDR05338 +3.5/RDR00002AC-993, RDR05327-000 +2.5/RDR00002AC-994, RDR05341-000 +2.0/RDR00002AC-993, RDR05156-005 +1.5/RDR00002AC-995, RDR04282-004 +1.5/RDR00002AC-995, RDR05338 +2.0/RDR00002AC-993, RDR05168-006 +2.0/RDR00002AC-995, RDR04282-002 +2.0/RDR00002AC-996, RDR05156-005 +2.5/RDR00002AC-995, RDR05341-000 +1.5/RDR00002AC-993, RDR05168-006 +1.5/RDR00002AC-995, RDR05156-005 +2.0/RDR00002AC-995, RDR05156-004 +3.5/RDR00002AC-996, RDR05318 +3.5/RDR00002AC-993, RDR05318 +3.0/RDR00002AC-993, RDR04887 +3.5/RDR00002AC-993, RDR04282-004 +3.5/RDR00002AC-995, RDR04887 +2.5/RDR00002AC-993, RDR04282-002 +1.5/RDR00002AC-996, RDR05168-005 +2.0/RDR00002AC-994, RDR04282-002 +3.5/RDR00002AC-996, RDR05327-000 +1.5/RDR00002AC-994, RDR04887 +3.0/RDR00002AC-993, RDR05168-005 +3.5/RDR00002AC-994, RDR05168-006 +2.5/RDR00002AC-995, RDR05168-003/RDR00002AC-996, RDR04282-002 +2.5/RDR00002AC-996, RDR05318 +2.5/RDR00002AC-993, RDR05327-000 +3.0/RDR00002AC-994
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- Withdrawn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
- WBL TradingSostrene
- Device Name
- Reading glasses
- Model / Reference
- RDR00116SE RDR05113-000 +1.5, RDR00119SE, RDR00115SE RDR05307-006 +1.5, RDR00121SE RDR05254-000 +1.0, RDR00119SE +2.0, RDR00116SE RDR05113-000 +1.0, RDR00119SE +3.0, RDR00121SE RDR05254-000 +2.0, RDR00120SE RDR05346-002 +1.5, RDR00117SE RDR05345-002 +1.0, RDR00121SE RDR05254-000 +1.5, RDR05111-001 +3.0, RDR00115SE RDR05307-006 +2.5, RDR00116SE RDR05113-000 +3.0, RDR00115SE RDR05307-006 +2.0, RDR00120SE RDR05346-002 +2.0, RDR00120SE RDR05346-002 +3.0, RDR05156-004 +1.5/RDR00002AC-996, RDR05301-000 +3.0/RDR00002AC-994, RDR05338 +3.5/RDR00002AC-993, RDR05327-000 +2.5/RDR00002AC-994, RDR05341-000 +2.0/RDR00002AC-993, RDR05156-005 +1.5/RDR00002AC-995, RDR04282-004 +1.5/RDR00002AC-995, RDR05338 +2.0/RDR00002AC-993, RDR05168-006 +2.0/RDR00002AC-995, RDR04282-002 +2.0/RDR00002AC-996, RDR05156-005 +2.5/RDR00002AC-995, RDR05341-000 +1.5/RDR00002AC-993, RDR05168-006 +1.5/RDR00002AC-995, RDR05156-005 +2.0/RDR00002AC-995, RDR05156-004 +3.5/RDR00002AC-996, RDR05318 +3.5/RDR00002AC-993, RDR05318 +3.0/RDR00002AC-993, RDR04887 +3.5/RDR00002AC-993, RDR04282-004 +3.5/RDR00002AC-995, RDR04887 +2.5/RDR00002AC-993, RDR04282-002 +1.5/RDR00002AC-996, RDR05168-005 +2.0/RDR00002AC-994, RDR04282-002 +3.5/RDR00002AC-996, RDR05327-000 +1.5/RDR00002AC-994, RDR04887 +3.0/RDR00002AC-993, RDR05168-005 +3.5/RDR00002AC-994, RDR05168-006 +2.5/RDR00002AC-995, RDR05168-003/RDR00002AC-996, RDR04282-002 +2.5/RDR00002AC-996, RDR05318 +2.5/RDR00002AC-993, RDR05327-000 +3.0/RDR00002AC-994
- Primary DI / UDI-DI
- 06977679604041, 06977679604218, 06977679604096, 06977679603983, 06977679604201, 06977679604034, 06977679604225, 06977679604003, 06977679604140, 06977679603938, 06977679603990, 06977679603174, 06977679604119, 06977679604072, 06977679604102, 06977679604157, 06977679604171, 06977679602412, 06977679602863, 06977679603877, 06977679602801, 06977679603891, 06977679602634, 06977679602689, 06977679603846, 06977679602597, 06977679602467, 06977679602658, 06977679603884, 06977679602580, 06977679602641, 06977679602443, 06977679603778, 06977679603761, 06977679603822, 06977679602726, 06977679603785, 06977679602450, 06977679602740, 06977679602481, 06977679602788, 06977679603815, 06977679602771, 06977679602603, 06977679602399, 06977679602474, 06977679603754, 06977679602818, 06977679602405
- Basic UDI-DI
- 697767960REGLY4
- Direct Marketing DI
- 06977679604041069776796042180697767960409606977679603983069776796042010697767960403406977679604225069776796040030697767960414006977679603938069776796039900697767960317406977679604119069776796040720697767960410206977679604157069776796041710697767960241206977679602863069776796038770697767960280106977679603891069776796026340697767960268906977679603846069776796025970697767960246706977679602658069776796038840697767960258006977679602641069776796024430697767960377806977679603761069776796038220697767960272606977679603785069776796024500697767960274006977679602481069776796027880697767960381506977679602771069776796026030697767960239906977679602474069776796037540697767960281806977679602405
- EMDN Code
- Q0210030101, Q0210030102
- 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