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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

TRIAMED, GENU REHA COOL ROM,… — Class I MDR by SC TRIAMED SRL

MD Atlas
SC TRIAMED SRL

EUDAMED last updated this device on Apr 23, 2025

TRIAMED, GENU REHA COOL ROM, Mobile knee brace with adjustable articulations

594476005ORTMEMBRULINFDS

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SC TRIAMED SRL
UDI-DI code: 05944760055595
Reference / catalog number: SRT326

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View device family (Basic UDI)

Manufacturer information

Organization name: SC TRIAMED SRL
SRN: RO-MF-000002843
Manufacturer status: Active

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Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW011
Consult instruction for use: The product should only be applied in accordance with the instruction for use. Single patient multiple use: The product is intended for single patient use.

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Market distribution

Primary placement in Romania; available across 1 country total.

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

Device identification

Trade name: TRIAMED, GENU REHA COOL ROM, Mobile knee brace with adjustable articulations
UDI-DI code: 05944760055595
Basic UDI-DI: 594476005ORTMEMBRULINFDS
Reference / catalog number: SRT326
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: https://www.triamed.ro/en/lower-limb-orthoses/genu-reha-cool-rom-1625
Clinical sizes: Universal size, for knee circumference between 30-52 cm.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)05944760055595

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Y061209KNEE 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

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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.