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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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Plenhyage XL Strong — 1 UDI-DI variant, MDD

MD Atlas
I.R.A. Istituto Ricerche Applicate S.p.A.

Data from EUDAMED, last updated May 30, 2026

Plenhyage XL Strong

B-08021822402096

1 UDI-DI variant

MDD [Directive 93/42/EEC on medical devices]Class III

Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class III
Manufacturer: I.R.A. Istituto Ricerche Applicate S.p.A.

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Device characteristics

ImplantableAnimal tissues / cells

Clinical investigations

Registered: No

Registered: No

Legacy certificates

Certificate number: EPG021719, QCT004017
Type: refdata.legacy.mdd-certificate-type.ii-4
Notified body: ISTITUTO SUPERIORE DI SANITA' (0373)
Validity: Dec 31, 2027

Identity & classification

Basic UDI-DI: B-08021822402096
Device name: Plenhyage XL Strong
Issuing agency: EUDAMED
Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class III
Version date: Dec 4, 2025

Manufacturer & authorised representative

Manufacturer

Name: I.R.A. Istituto Ricerche Applicate S.p.A.
SRN: IT-MF-000009981
Country: Italy
Email: info@iralab.it
Phone: +39039631741

Variants by status

UDI-DI variants

1 UDI-DI variant

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Applied filters

basicUdiUlid01KBM81RVJ16ZGAFBBE5VSWBVX

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

Plenhyage XL Strong08021822402096