Identity
- Trade Name
- Epi Clear EUDAMED
- Device Name
- EPI Clear EUDAMED
- Model / Reference
- EPI Clear EUDAMEDEP-20-006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 17290016549062 EUDAMED
- Basic UDI-DI
- 7290016549EPI-ClearM6 EUDAMED
- Unit of Use DI
- 17290016549093 EUDAMED
- EMDN Code
- Q021199 OPHTHALMIC SURGERY INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
Epi Clear by Orca Surgical — 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 | 7290016549EPI-ClearM6 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Orca Surgical
- EUDAMED SRN
- IL-MF-000012154
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (1)
- EUDAMED 90e57872-9e7c-48bd-8c9c-62d60f70e8d6 61 fields · synced Jun 18, 2026