Opia

by Opi̇a İnovasyon Sağlik Medi̇kal Arge Ve Danişmanlik San. Diş Ti̇c. A.Ş. 34 variants

Ref OP-00201-04 XLModel OP00201

Active European Union

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number86836284OP00201N2 Basic UDI-DI 08683628400036UDI-DI	Date12 Jun 2022Registered	StatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name: Sterile Single Use Surgical Gown, Opia
Model / Reference: OP00201, OP-00201-04 XL

Primary DI / UDI-DI: 08683628400036
Basic UDI-DI: 86836284OP00201N2
EMDN Code: T020401 Standard surgical gowns

Device Class: Class I
EU market of registration: Italy

Manufacturer details

EUDAMED SRN: TR-MF-000021222

Other devices from Opi̇a İnovasyon Sağlik Medi̇kal Arge Ve Danişmanlik San. Diş Ti̇c. A.Ş.

Opi̇a

Class I
T020401

Class I
Opi̇a

Class I
Opia

Class I
Opia

Class I
Opi̇a

Class I

See all devices from Opi̇a İnovasyon Sağlik Medi̇kal Arge Ve Danişmanlik San. Diş Ti̇c. A.Ş. →

Properties

Sterile

Other properties (12)

Implantable: No
Reusable: No
Contains Latex: No
Reprocessed: No
CMR Substance: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Endocrine Disruptor: No
Administering Medicine: No
Measuring Function: No
Incorporates Medicinal Product: No