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Plášť operační NADSTANDARD CLASSIC sv. modrá/tm. modrá vel. 3XL základní

by CLINITEX s.r.o.

Ref N16CAAA1KDUHAHB00009, N16CAAA1KDUHAHB00109, N16CAAA1KDUHAHB00909

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number859420696CLIX002SH Basic UDI-DI Date23 Jan 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Trade Name
Plášť operační NADSTANDARD CLASSIC sv. modrá/tm. modrá vel. 3XL základní
Plášť operační NADSTANDARD CLASSIC sv. modrá/tm. modrá vel. 3XL prodloužená
Plášť operační NADSTANDARD CLASSIC sv. modrá/tm. modrá vel. 3XL zkrácená
Device Name
Plášť operační NADSTANDARD
Model / Reference
N16CAAA1KDUHAHB00009, N16CAAA1KDUHAHB00109, N16CAAA1KDUHAHB00909
Primary DI / UDI-DI
08594206966519, 08594206966601, 08594206966694
Basic UDI-DI
859420696CLIX002SH
EMDN Code
T020402 Reinforced surgical gowns
Device Class
Class I
EU market of registration
Czechia

Manufacturer details

EUDAMED SRN
CZ-MF-000051598

Other devices from CLINITEX s.r.o.

See all devices from CLINITEX s.r.o. →

Properties

Other properties (13)

  • Sterile: No
  • 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