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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Pixie CO2 — 5 UDI-DI variants, MDR (Oystershell NV)

MD Atlas
Oystershell NV

Data from EUDAMED, last updated May 23, 2026

Pixie CO2

5410765PixieCO2FQ

5 UDI-DI variants

MDR [Regulation (EU) 2017/745 on medical devices]Class IIa

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Manufacturer: Oystershell NV

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 5410765PixieCO2FQ
Device name: Pixie CO2
Device model: X92001686
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Version date: Nov 21, 2025

Manufacturer & authorised representative

Manufacturer

Name: Oystershell NV
SRN: BE-MF-000011797
Country: Belgium
Email: regulatory@oystershell.be
Phone: 0032.09.377.24.85

Variants by status

UDI-DI variants

5 UDI-DI variants

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Applied filters

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Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

Expert 1.2.3 CRYOSTYLO FROID EXTREME05410765005625
WORTIE FREEZE PRO05410765005687
WORTIE FREEZE PRO05410765009616
0701154105410765005694
0701175905410765009654