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Epi Clear
EUDAMEDClass IIa (EU MDR)
Ref EP-04-006Model EPI ClearRef EP-20-007Ref EP-04-007Ref EP-10-007Ref EP-10-006
Identity
- Trade Name
- Epi Clear EUDAMED
- Device Name
- EPI Clear EUDAMED
- Model / Reference
- EPI Clear EUDAMEDEP-04-006 EUDAMEDEP-20-007 EUDAMEDEP-04-007 EUDAMEDEP-10-007 EUDAMEDEP-10-006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 17290016549000 EUDAMED17290016549079 EUDAMED17290016549017 EUDAMED17290016549055 EUDAMED17290016549048 EUDAMED
- Basic UDI-DI
- 7290016549EPI-ClearM6 EUDAMED
- Unit of Use DI
- 17290016549093 EUDAMED17290016549086 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 (5)
- EUDAMED ab1be462-47d6-42cf-ab7b-42fd30507cbb 61 fields · synced Aug 3, 2026
- EUDAMED 0ca45b2a-ab0d-47d1-96cc-08d6f1e98e03 61 fields · synced May 18, 2026
- EUDAMED 72cdf2ca-fcac-4940-86a5-88a9ec5be68e 61 fields · synced May 18, 2026
- EUDAMED a7d6ae71-313d-466a-9d38-e58548702aca 61 fields · synced May 18, 2026
- EUDAMED 262c37c5-3ff0-464a-96b1-4ed00a21014b 61 fields · synced May 18, 2026