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MI+BW-Mantel M

by Rosa Toifl & Co GmbH 22 variants

Ref 47002

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number9010845OP-Mantel-QK Basic UDI-DI 09010845001019UDI-DIDate22 Feb 2023RegisteredStatusActive

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  • Withdrawn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

Device Name
MI+BW-Mantel "M"
Model / Reference
47002
Primary DI / UDI-DI
09010845001019
Basic UDI-DI
9010845OP-Mantel-QK
Direct Marketing DI
09010845001019
EMDN Code
T020401 Standard surgical gowns
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
AT-MF-000020516

Other devices from Rosa Toifl & Co GmbH

See all devices from Rosa Toifl & Co GmbH →

Properties

  • Reprocessed

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: 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