EUDAMED last updated this device on Aug 19, 2026

ANKLE BRACE + VELCRO BOTA PLUS BLACK LEFT XLARGE = + 25 cm

54040208BRACES6M

On the marketClass I

Applicable legislation: —
Organization name: LABORATORIA BOTA NV
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 05404020810215
Reference / catalog number: 222001040

Regulatory classification unavailableThis product's Basic UDI record hasn't been published in EUDAMED yet. Classification and compliance details will appear automatically once EUDAMED publishes it.

ANKLE BRACE + VELCRO BOTA PLUS BLACK LEFT XLARGE = + 25 cm is an EU-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by LABORATORIA BOTA NV. Placed on the EU market in Belgium. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: ANKLE BRACE + VELCRO BOTA PLUS BLACK LEFT XLARGE = + 25 cm
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 05404020810215
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. View in glossary →: 54040208BRACES6M
Reference / catalog number: 222001040
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: GS1

Classification

Risk category: Class I
Applicable legislation: —
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)05404020810215

UDI-PI DataMatrix

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

EMDN nomenclature code(s)

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

M0304010101ELASTIC COMPRESSION BANDAGES, NON-ADHESIVE, LOW EXTENSIBILITY (<70%)

Critical warnings

No critical warnings reported for this device.

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Certificates covering this device

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

Market distribution

Primary placement in Belgium; available across 11 countries total.

Country	On market since	Until
BelgiumPrimary placement	—	Still on market
Austria	—	Still on market
Germany	—	Still on market
Denmark	—	Still on market
Spain	—	Still on market
France	—	Still on market
Italy	—	Still on market
Luxembourg	—	Still on market
Netherlands	—	Still on market
Portugal	—	Still on market
Sweden	—	Still on market

Related searches

Class I medical devices in EUDAMED

Device identification

Trade name: ANKLE BRACE + VELCRO BOTA PLUS BLACK LEFT XLARGE = + 25 cm
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 05404020810215
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. View in glossary →: 54040208BRACES6M
Reference / catalog number: 222001040
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: GS1

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Certificates

No certificates registered for this manufacturer.

Market distribution

Primary placement in Belgium; available across 11 countries total.

Country	On market since	Until
BelgiumPrimary placement	—	Still on market
Austria	—	Still on market
Germany	—	Still on market
Denmark	—	Still on market
Spain	—	Still on market
France	—	Still on market
Italy	—	Still on market
Luxembourg	—	Still on market
Netherlands	—	Still on market
Portugal	—	Still on market
Sweden	—	Still on market

ANKLE BRACE + VELCRO BOTA PLUS BLACK LEFT XLARGE = + 25 cm

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates covering this device

Market distribution

Related searches

Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates

Related devices