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Organization name
UDI-DI code
Reference / catalog number

Hi-Torque connect — Class IIa MDR by Lake Region Medical…

MD Atlas
Lake Region Medical (Galway)

EUDAMED last updated this device on Mar 30, 2026

Hi-Torque connect

081634901HTCGW82

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Lake Region Medical (Galway)
UDI-DI code: 00816349014895
Reference / catalog number: 1012588

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Manufacturer information

Organization name: Lake Region Medical (Galway)
SRN: IE-MF-000035376
Manufacturer status: Active

Critical warnings

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

CW999
Hi-Torque™ Guidewires are not intended for use in the coronary and cerebral vasculature or in patients judged not acceptable for percutaneous intervention.

Market distribution

Primary placement in Ireland; available across 1 country total.

Country	On market since	Until
IrelandPrimary placement		Still on market

Device identification

Trade name: Hi-Torque connect
UDI-DI code: 00816349014895
Basic UDI-DI: 081634901HTCGW82
Reference / catalog number: 1012588
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Hi-Torque Connect, 0.018”, 195cm, 4g, Straight
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 195 cm

EMDN nomenclature code(s)

C04020299PERIPHERAL VASCULAR GUIDEWIRES, THERAPEUTICAL - 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

Related devices

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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.