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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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HEAVY INCO — 1 UDI-DI variant, MDR (Serenity Spa)

MD Atlas
Serenity Spa

Data from EUDAMED, last updated May 30, 2026

HEAVY INCO

805815056Ser-HeavyIncoJV

1 UDI-DI variant

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

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Manufacturer: Serenity Spa

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 805815056Ser-HeavyIncoJV
Device name: —
Device model: HEAVY INCO
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Version date: Feb 16, 2023

Manufacturer & authorised representative

Manufacturer

Name: Serenity Spa
SRN: IT-MF-000010810
Country: Italy
Email: francesco.lopiccolo@ontexglobal.com

Variants by status

UDI-DI variants

1 UDI-DI variant

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Applied filters

basicUdiUlid01GSB1H205ZS03BHD0M9ZPMGCJ

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

3919215002108058150568941