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Opi̇a

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

Ref OIM(SMS)-0302-01S, OP-00202-02 M, OP-01026-01, OP-00203-04 XL, OP-00206-01 S, OIM(SMS)-0302-04XL, OP-00203-05 2XL, HIGH-RII, OIM(SMS)-0402-074XL, OP-00203-03 L, OP-00203-01 S, OIM(SMS)-0302-03L, OP-00203-06 3XL, OP-00206-05 2XL, OIM(SMS)-0402-01S, OP-00204-01 S, OP-00205-06 3XL, OP-00201-03 L, OP-00204-03 L, HIGH-RIII, OP-00206-03 L, OP-00205-04 XL, OP-00205-02 M, OIM(SMS)-0402-063XL, OP-00204-05 2XL, OP-01029-01, OP-00205-03 L, OP-00202-06 3XL, OP-01032-01, OP-00101-03 L, OP-00201-02 M, OP-00101-01 S, OP-01027-01, OP-00101-05 2XL, OP-00101-04 XL, OIM(SMS)-0402-03LModel OIM(SMS)-0302, OP-00202, OP-00203, OP-00206, HIGH, OIM(SMS)-0402, OP-00204, OP-00205, OP00201, OP-00101

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number86836284OIM(SMS)0302KE Basic UDI-DI Date26 Aug 2022RegisteredStatusActive

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

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Disposable Surgical Overall- Type 5/6
Disposable Reinforced Sterile Surgical Gown
Obstetrics Sterile Set
Disponsable Full Reinforced Sterile Surgical Gown
Disposable Chemotherapy Surgical Gown
OPIA-Disposable 4 Ply Surgical Mask
Disposable Surgical Overall-Type 3/4
Disposable Sterile Surgical Urology Gown, Opi̇a
Disposable Biflex Surgical Gown
Sterile Single Use Surgical Gown, Opia
Urology Surgery Sterile Set
Kvc Angiosurgical Sterile Set
Disposable Surgical Isolation Gown
Eye Sterile Set
Model / Reference
OIM(SMS)-0302, OIM(SMS)-0302-01S, OP-00202, OP-00202-02 M, OP-01026-01, OP-00203, OP-00203-04 XL, OP-00206, OP-00206-01 S, OIM(SMS)-0302-04XL, OP-00203-05 2XL, HIGH, HIGH-RII, OIM(SMS)-0402, OIM(SMS)-0402-074XL, OP-00203-03 L, OP-00203-01 S, OIM(SMS)-0302-03L, OP-00203-06 3XL, OP-00206-05 2XL, OIM(SMS)-0402-01S, OP-00204, OP-00204-01 S, OP-00205, OP-00205-06 3XL, OP00201, OP-00201-03 L, OP-00204-03 L, HIGH-RIII, OP-00206-03 L, OP-00205-04 XL, OP-00205-02 M, OIM(SMS)-0402-063XL, OP-00204-05 2XL, OP-01029-01, OP-00205-03 L, OP-00202-06 3XL, OP-01032-01, OP-00101, OP-00101-03 L, OP-00201-02 M, OP-00101-01 S, OP-01027-01, OP-00101-05 2XL, OP-00101-04 XL, OIM(SMS)-0402-03L
Primary DI / UDI-DI
08683628400616, 08683628400098, 08683628400074, 08683628400180, 08683628400777, 08683628400586, 08683628400197, 08683628401347, 08683628400487, 08683628400173, 08683628400159, 08683628400593, 08683628400203, 08683628400814, 08683628400548, 08683628400265, 08683628400760, 08683628400029, 08683628400289, 08683628401354, 08683628400791, 08683628400708, 08683628400739, 08683628400494, 08683628400302, 08683628400227, 08683628400722, 08683628400135, 08683628400241, 08683628401002, 08683628400012, 08683628400982, 08683628400142, 08683628401019, 08683628400845, 08683628400517
Basic UDI-DI
86836284OIM(SMS)0302KE, 86836284OP00202N4, 86836284OP0102601V7, 86836284OP00203N6, 86836284OP00206NC, 86836284HIGHYC, 86836284OIM(SMS)0402KK, 86836284OP00204N8, 86836284OP00205NA, 86836284OP00201N2, 86836284OP0102901VN, 86836284OP0103201US, 86836284OP00101MV, 86836284OP0102701VC
EMDN Code
T020401, T0202, T020402, T020604, T020499
Device Class
Class I
EU market of registration
Italy
Austria

Manufacturer details

EUDAMED SRN
TR-MF-000021222

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

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

Properties

  • Sterile NoEUDAMEDYesEUDAMED
  • Administering Medicine NoEUDAMEDYesEUDAMED

Other properties (11)

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