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MiniMe 2 Pediatric Nasal Non Vented Mask, Medium 60258

by Sleepnet Corporation EUDAMEDGUDID

Active European Union

Ref 60258

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00814747024812 UDI-DIDate6 May 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number08147470213MW Basic UDI-DIDate30 Jun 2025RegisteredStatusActive

Coverage

2 jurisdictions

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  • Withdrawn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

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
MiniMe 2 Pediatric Nasal Non Vented, Medium EUDAMED
MiniMe 2 Pediatric Nasal Non Vented Mask, Medium GUDID
Generic Name
CPAP/BPAP nasal mask, reusable
Device Name
Pediatric Nasal Mask
Model / Reference
60258
Primary DI / UDI-DI
00814747024812
Basic UDI-DI
08147470213MW
FDA Product Code
BZD
EMDN Code
R0301010202 Niv masks
GMDN Term
CPAP/BPAP nasal mask, reusable
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
868.5905
Market of Registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

From the manufacturer

Manufacturer's product page: MiniMe® Nasal Pediatric Mask Big comfort for small patients

Other devices from Sleepnet Corporation

See all devices from Sleepnet Corporation →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing 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
  • Expiration Date: No