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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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Organization name
UDI-DI code
Reference / catalog number

Thermoplastic material for… — Class I MDR by Orfit Industries

MD Atlas
Orfit Industries

EUDAMED last updated this device on Mar 2, 2026

Thermoplastic material for orthotics and prosthetics.

5420028700014L

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Orfit Industries
UDI-DI code: 05420028722381
Reference / catalog number: 37SS/4480B

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Manufacturer information

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

Market distribution

Primary placement in Belgium; available across 2 countries total.

Country	On market since	Until
BelgiumPrimary placement		Still on market
Bulgaria		Still on market

Device identification

Trade name: Thermoplastic material for orthotics and prosthetics.
UDI-DI code: 05420028722381
Basic UDI-DI: 5420028700014L
Reference / catalog number: 37SS/4480B
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: ORFITRANS is a high melting temperature thermoplastic material for the production of external orthoses and prosthetic check and inner sockets.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y061299LOWER EXTREMITY ORTHOSES - OTHER

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

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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.