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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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FIBRILIN vial 3 ml — 2 UDI-DI variants, MDR

MD Atlas
LABORATORIOS FARMACÉUTICOS ROVI, S.A.

Data from EUDAMED, last updated May 31, 2026

FIBRILIN vial 3 ml

843658324FIBRILIN7Q

2 UDI-DI variants

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

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class III
Manufacturer: LABORATORIOS FARMACÉUTICOS ROVI, S.A.

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Device characteristics

Incorporates a medicinal productAnimal tissues / cells

Legacy certificates

Certificate number: 2026 DR 0079
Type: refdata.certificate-mdr-type.technical-documentation
Notified body: CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS (0318)
Validity: Feb 23, 2026 → Feb 22, 2031

Identity & classification

Basic UDI-DI: 843658324FIBRILIN7Q
Device name: FIBRILIN vial 3 ml
Device model: FIBRILIN vial 3 ml
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class III
Version date: May 21, 2026

Manufacturer & authorised representative

Manufacturer

Name: LABORATORIOS FARMACÉUTICOS ROVI, S.A.
SRN: ES-MF-000014579
Country: Spain
Email: sortiz@rovi.es

Variants by status

UDI-DI variants

2 UDI-DI variants

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Applied filters

basicUdiUlid01KS5E57BGRMFK6TQJ0V0AX8K2

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

FIBRILIN vial 3 ml08436583241240
FIBRILIN vial 5 ml08436583241257