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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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ENGIpore Ortho — 1 UDI-DI variant, MDD (Fin-ceramica faenza spa)

MD Atlas
Fin-ceramica faenza spa

Data from EUDAMED, last updated May 30, 2026

ENGIpore Ortho

B-18054188160055

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: Fin-ceramica faenza spa

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Device characteristics

Implantable

Legacy certificates

Certificate number: QCT-0066-17
Type: refdata.legacy.mdd-certificate-type.ii-excluding-4
Notified body: ISTITUTO SUPERIORE DI SANITA' (0373)
Validity: Dec 12, 2022

Certificate number: EPG-0066-17
Type: refdata.legacy.mdd-certificate-type.ii-4
Notified body: ISTITUTO SUPERIORE DI SANITA' (0373)
Validity: Dec 12, 2022

Identity & classification

Basic UDI-DI: B-18054188160055
Device name: ENGIpore Ortho
Device model: PFS015005-21-00
Issuing agency: EUDAMED
Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class III
Version date: Oct 21, 2022

Manufacturer & authorised representative

Manufacturer

Name: Fin-ceramica faenza spa
SRN: IT-MF-000023496
Country: Italy
Email: info@finceramica.it
Phone: +39 0546 607311

Variants by status

UDI-DI variants

1 UDI-DI variant

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basicUdiUlid01G9PMBJFARPR8G7J3N1Q4BD2F

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

ENGIpore Ortho18054188160055