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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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HYAL SYSTEM 1.8% — 1 UDI-DI variant, MDD (Fidia Farmaceutici S.p.A.)

MD Atlas
Fidia Farmaceutici S.p.A.

Data from EUDAMED, last updated May 30, 2026

HYAL SYSTEM 1.8%

B-100012643C

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: Fidia Farmaceutici S.p.A.

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Device characteristics

Implantable

Legacy certificates

Certificate number: QCT-0168-21
Type: refdata.legacy.mdd-certificate-type.ii-excluding-4
Notified body: ISTITUTO SUPERIORE DI SANITA' (0373)
Validity: Dec 31, 2027

Certificate number: EPG-0362-21
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-100012643C
Device name: HYAL SYSTEM 1.8%
Device model: QQE1-01-1C2
Issuing agency: EUDAMED
Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class III
Version date: May 7, 2026

Manufacturer & authorised representative

Manufacturer

Name: Fidia Farmaceutici S.p.A.
SRN: IT-MF-000026988
Country: Italy
Email: agastaIdi@fidiapharma.it

Variants by status

UDI-DI variants

1 UDI-DI variant

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basicUdiUlid01KR0REDVQQA3Y4DCQD8GFHWXQ

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

10001264D-100012643C