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Epi Clear

by Orca Surgical 2 variants

Ref EP-20-006Model EPI Clear

Epi Clear (EP-20-006) is a medical device (EU MDR Class IIa; EMDN category ophthalmic surgery instruments) made by Orca Surgical, registered in EUDAMED on 16 Feb 2026 (Basic UDI-DI 7290016549EPI-ClearM6), active as of 23 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number7290016549EPI-ClearM6 Basic UDI-DI 17290016549062UDI-DIDate16 Feb 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
EPI Clear, EP-20-006
Primary DI / UDI-DI
17290016549062
Basic UDI-DI
7290016549EPI-ClearM6
Unit of use DI
17290016549093
EMDN code
Q021199 Ophthalmic surgery instruments, single-use - other
Device class
Class IIa
EU registration type
Standard device
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
IL-MF-000012154
Authorised representative
MedEnvoy Global BV NL-AR-000024028

Similar devices in this category

Other devices filed under OPHTHALMIC SURGERY INSTRUMENTS, SINGLE-USE - OTHER.

Other devices from Orca Surgical

Properties

  • Supplied sterile
Other properties (13, all answered No)