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MicroMax Low Flow DISS

by Maxtec, Inc.

Ref R203P13

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

CE MDR

Valid until

No date given

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0853061006MICROMAXMW Basic UDI-DI 00853061006074UDI-DIDate5 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00853061006074 UDI-DI Date1 Nov 2015ListedStatusListed 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  • Withdrawn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

Trade name
MicroMax Low Flow Blender with DISS fitting EUDAMED
MicroMax GUDID
Generic name
Oxygen/air breathing gas mixer, hospital
Device name
MicroMax Air-Oxygen Blender
Model / Ref / Catalog
R203P13, Low Flow DISS
Primary DI / UDI-DI
00853061006074
Basic UDI-DI
0853061006MICROMAXMW
Direct marketing DI
00853061006074
FDA product code
BZR
EMDN code
R9099 Respiratory and anaesthesia devices - other
GMDN term
Oxygen/air breathing gas mixer, hospital
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
868.5330
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Weight — 2.29 Pound
Width — 2.3 Inch
Height — 4.1 Inch
Depth — 4.9 Inch

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
R203P13
GUDID
Low Flow DISS
Device classEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Oxygen/air breathing gas mixer, hospital

Other devices from Maxtec, Inc.

See all devices from Maxtec, Inc. →

Properties

  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Premarket exempt
  • Serial number

Other properties (21)

  • Supplied sterile: No
  • Sterilise before use: No
  • Single use: No
  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Lot / batch number: No
  • Expiration date: No
  • Manufacturing date: No