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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, OMBIFIX, Abdominal… — Class I MDR by SC TRIAMED SRL

MD Atlas
SC TRIAMED SRL

EUDAMED last updated this device on Mar 23, 2026

TRIAMED, OMBIFIX, Abdominal support for umbilical hernia

59447578ORTCOLOANAVERTUG

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SC TRIAMED SRL
UDI-DI code: 05944757804984
Reference / catalog number: SRT110M5BLACK

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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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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.

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

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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, OMBIFIX, Abdominal support for umbilical hernia
UDI-DI code: 05944757804984
Basic UDI-DI: 59447578ORTCOLOANAVERTUG
Reference / catalog number: SRT110M5BLACK
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: BLACK COLOUR
Additional information URL: https://www.triamed.ro/en/spinal-orthoses/ombifix-3133
Clinical sizes: Size M5, for waist circumference between 105-115 cm.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)05944757804984

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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.

Y060406ABDOMINAL HERNIA SUPPORTS

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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