SD01H-S (32)
by SEED Co., Ltd. Japan EUDAMED
Ref manyModel Sterile vision corrective contact lenses
EMDN Q021004010101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberJP26/00000021 | Date30 Apr 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- JP26/00000021 Amended
Quality management system EU MDR
- Notified body
- Notified body 1639
- Issued
- 30 Apr 2026
- Expires
- 22 Jan 2031
- Reason
- Mnf data change
Specification
- Model / Reference
- Sterile vision corrective contact lenses, many
- Primary DI / UDI-DI
- 496124321910S46
- Basic UDI-DI
- 4961243SEEDCL01Y3
- EMDN Code
- Q021004010101 Contact lenses - hydrogel, daily single-use
- Device Class
- Class IIa
- Special Device Type
- Standard soft contact lenses
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- JP-MF-000020702
- Authorised representative
- Wöhlk Contactlinsen GmbH DE-AR-000040895
Other devices from SEED Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- 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
Sources (1)
- EUDAMED 3d1feafb-bc8c-4984-9cf4-af216f0b795f