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MicroFrance®

by Integra MicroFrance 44 variants

Part of a family of 12 devices: see the family page

Ref 8812-2

MicroFrance® (8812-2) is a Class I device made by Integra Microfrance, registered in EUDAMED on 10 Jul 2026 (Basic UDI-DI 038178B0056CSS43), active as of 7 Nov 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, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number038178B0056CSS43 Basic UDI-DI 10381780090861UDI-DIDate10 Jul 2026RegisteredStatusActive

Official records

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  • Withdrawn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
Speculum
Model / reference
8812-2
Primary DI / UDI-DI
10381780090861
Basic UDI-DI
038178B0056CSS43
EMDN code
L149004 ENT speculums, reusable
Device class
Class I
EU registration type
Standard device
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
FR-MF-000011524

Similar devices in this category

Other devices filed under ENT SPECULUMS, REUSABLE.

Other devices from Integra Microfrance

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Properties

  • Sterilise before use
Other properties (13, all answered No)