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Organization name
UDI-DI code
Reference / catalog number

Paire de Maia - Pt 38 — Class I MDR by Romans Industrie

MD Atlas
Romans Industrie

EUDAMED last updated this device on May 26, 2025

Paire de Maia - Pt 38

37000985AUGMENTKD

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Romans Industrie
UDI-DI code: 03700098500181
Reference / catalog number: Paire de Maia - Pt 38

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Manufacturer information

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

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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.

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 Maia - Pt 38
UDI-DI code: 03700098500181
Basic UDI-DI: 37000985AUGMENTKD
Reference / catalog number: Paire de Maia - Pt 38
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: Paire de Maia - Pt 38
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 38 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