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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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HEALON DUET PRO II — 1 UDI-DI variant, MDR (AMO Uppsala AB)

MD Atlas
AMO Uppsala AB

Data from EUDAMED, last updated May 31, 2026

HEALON DUET PRO II

5050474a000679Y

1 UDI-DI variant

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

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIb
Manufacturer: AMO Uppsala AB

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 5050474a000679Y
Device name: HEALON DUET PRO II
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIb
Version date: Apr 9, 2026

Manufacturer & authorised representative

Manufacturer

Name: AMO Uppsala AB
SRN: SE-MF-000017467
Country: Sweden
Email: RA-VISEU-DUVigilance@ITS.JNJ.com
Phone: +46 18 166 700

Variants by status

UDI-DI variants

1 UDI-DI variant

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Applied filters

basicUdiUlid01KNSJ03ZRJME07TWVEPZYV4DZ

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

HEALON DUET PRO II05050474755123