Identity
- Device Name
- OpClear Platform EUDAMED
- Model / Reference
- CU3DI3 EUDAMEDCS-CU33 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 50603468008066 EUDAMED
- Basic UDI-DI
- 506034680CU3DI3Y5 EUDAMED
- Direct Marketing DI
- 50603468003184 EUDAMED
- EMDN Code
- Z12019007 IRRIGATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
No
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
Category: Endoscopic spray catheter, single-use
OpClear Platform by Cipher Surgical Limited — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 (1)
- EUDAMED 2d7c09c6-44c2-4a4d-b19e-8de5ec30b6fe 61 fields · synced May 23, 2026