BrownGuard 2000 thumb brace type 01

Organization name

ARIES, a.s.

SRN

CZ-MF-000047385

Manufacturer status

Active

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

• When not to use: Discontinue use of the medical device immediately if: • signs of mechanical damage appear (replace the brace with a new one) • you observe a deterioration in your health that may be related to the use of the thumb brace –⁠ in such a case, consult with your treating physician Contraindications: • skin diseases or injuries in the thumb area • acute weeping skin manifestations • hypersensitivity to materials used • limb sensitivity disorders, peripheral neuropathy

  OTHER

Primary placement in Czechia; available across 1 country total.

Trade name

BrownGuard 2000 thumb brace type 01

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

08590072839896

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

859007220230738

Reference / catalog number

NA

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

The medical device is designed for stabilising the thumb during post-injury and postoperative therapy, preventing swelling and providing support for laxity, inflammation or injuries to the ligaments and tendons of the thumb.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• M
• 9999
• double-sided

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

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

• Y060603FINGERS ORTHOSES

• Class I medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.