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

3DF/BL/1.75/0.5 — Class I MDR by Orfit Industries

MD Atlas
Orfit Industries

EUDAMED last updated this device on Feb 26, 2025

3DF/BL/1.75/0.5

54200287061JU

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Orfit Industries
UDI-DI code: 54011720038496
Reference / catalog number: 3DF/BL/1.75/0.5

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: Orfit Industries
SRN: BE-MF-000007872
Manufacturer status: Active

Related devices

Raycast® High Precision – Thermoplastic Bolus Material54200287002858On the market Raycast® High Precision – Thermoplastic Bolus Material54200287002858On the market 3DF/W/2.85/0.554200287061JUOn the market 3DF/W/1.75/0.554200287061JUOn the market 3DF/W/1.75/154200287061JUOn 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.

Market distribution

Primary placement in Belgium; available across 1 country total.

Placed on the market in Belgium; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 54011720038496
Basic UDI-DI: 54200287061JU
Reference / catalog number: 3DF/BL/1.75/0.5
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y060613WRIST-HAND-FINGERS ORTHOSES

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