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M-Flex

by Diversatek Healthcare 46 variants

Ref 1206-20

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081673402120612072N Basic UDI-DI 00816734020005UDI-DIDate10 May 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00816734020005 UDI-DI Date17 Sep 2016ListedStatusListed GUDID: in commercial distribution

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

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Oesophageal bougie, reusable
Device Name
M-Flex Blue Silicone Bougie
Model / Ref / Catalog
1206-20
Primary DI / UDI-DI
00816734020005
Basic UDI-DI
081673402120612072N
Direct Marketing DI
00816734020005
FDA Product Code
FAT
EMDN Code
G010101 Oesophageal bougies
GMDN Term
Oesophageal bougie, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
876.5365
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Size
Catheter Gauge — 20 French

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000041616
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Diversatek Healthcare

See all devices from Diversatek Healthcare →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (21)

  • Sterile: No
  • Single Use: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No