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OpClear Platform
EUDAMEDClass IIa (EU MDR)
Ref CS-10-30-315Model CU3DI3Ref CS-10-30-330Ref CS-10-30-300Ref CS-10-00-315Ref CS-10-00-330Ref CS-10-00-300
Identity
- Device Name
- OpClear Platform EUDAMED
- Model / Reference
- CU3DI3 EUDAMEDCS-10-30-315 EUDAMEDCS-10-30-330 EUDAMEDCS-10-30-300 EUDAMEDCS-10-00-315 EUDAMEDCS-10-00-330 EUDAMEDCS-10-00-300 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 50603468009810 EUDAMED50603468010014 EUDAMED50603468009674 EUDAMED50603468009742 EUDAMED50603468009988 EUDAMED50603468009506 EUDAMED
- Basic UDI-DI
- 506034680CU3DI3Y5 EUDAMED
- Unit of Use DI
- 50603468008684 EUDAMED50603468008820 EUDAMED50603468008448 EUDAMED50603468008516 EUDAMED50603468008752 EUDAMED50603468008370 EUDAMED
- EMDN Code
- Z12029015 LENS CLEANING UNITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
OpClear Platform by Cipher Surgical Limited — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 506034680CU3DI3Y5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Cipher Surgical Limited.
- EUDAMED SRN
- GB-MF-000008065
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (6)
- EUDAMED 14dfd778-12ca-4dd6-8330-819e1466a726 61 fields · synced Jul 26, 2026
- EUDAMED ff4a1326-5ccb-4116-8381-35bbe80170bb 61 fields · synced May 16, 2026
- EUDAMED e0e8395c-a81d-40b6-b307-f638d80c5e12 61 fields · synced May 18, 2026
- EUDAMED cd1de081-30ac-4885-8d08-0b5f8be932a1 61 fields · synced May 18, 2026
- EUDAMED 274c6311-d5f7-4347-9fcb-e848c025eb42 61 fields · synced May 18, 2026
- EUDAMED 337a0817-690d-4747-9a01-e2266d824830 61 fields · synced May 18, 2026