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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

SRT211M2R — Class I MDR by SC TRIAMED SRL

MD Atlas
SC TRIAMED SRL

EUDAMED last updated this device on Apr 8, 2025

SRT211M2R

594476005ORTMEMBRULSUPGM

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SC TRIAMED SRL
UDI-DI code: 05944760052853
Reference / catalog number: SRT211M2R

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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: not provided
UDI-DI code: 05944760052853
Basic UDI-DI: 594476005ORTMEMBRULSUPGM
Reference / catalog number: SRT211M2R
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/upper-limb-orthoses/fixed-wrist-hand-brace
Clinical sizes: Size M2, right hand, for wrist circumference between 17-19 cm.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)05944760052853

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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.

Y060612WRIST-HAND 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.