Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

PAIRE DE IFOS PT 45/46 — Class I MDR by Romans Industrie

MD Atlas
Romans Industrie

EUDAMED last updated this device on May 7, 2025

PAIRE DE IFOS PT 45/46

37000985DECHARGEHD

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Romans Industrie
UDI-DI code: 03700098500471
Reference / catalog number: PAIRE DE IFOS PT 45/46

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

Organization name: Romans Industrie
SRN: FR-MF-000011961
Manufacturer status: Active

Market distribution

Primary placement in France; available across 3 countries total.

Country	On market since	Until
FrancePrimary placement		Still on market
Belgium		Still on market
Romania		Still on market

Device identification

Trade name: PAIRE DE IFOS PT 45/46
UDI-DI code: 03700098500471
Basic UDI-DI: 37000985DECHARGEHD
Reference / catalog number: PAIRE DE IFOS PT 45/46
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Chaussure post-opératoire à décharge de l'avant pied - paire de IFOS pt 45/46
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 45–46 MU999

EMDN nomenclature code(s)

Y063303READY-MADE ORTHOTIC SHOES

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

PERCULIGHT GAUCHE PT 35/3637000985DECHARGEHDOn the market Percusoft - Droit - Pt 35/3637000985DECHARGEHDOn the market Percusoft - Droit - Pt 41/4237000985DECHARGEHDOn the market Percusoft - Droit - Pt 43/4437000985DECHARGEHDOn the market Percusoft - Droit - Pt 45/4637000985DECHARGEHDOn the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.