EUDAMED last updated this device on Jul 29, 2026

BackieBelt

08588008909BackieBeltU3

On the marketClass I

Applicable legislation: —
Organization name: MAR´CO, s.r.o.
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 →: 08588008909041
Reference / catalog number: REF-BB001-S

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.

BackieBelt is an EU-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by MAR´CO, s.r.o.. Placed on the EU market in Slovakia. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: BackieBelt
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 →: 08588008909041
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 →: 08588008909BackieBeltU3
Reference / catalog number: REF-BB001-S
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: This device is a prefabricated, non-custom, externally applied orthopedic support designed to provide stabilization or immobilization of the lower lumbar spine. It is indicated for use in managing conditions such as spinal deformities, fractures, sprains, or strains. The device is reusable and suitable for repeated application.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 83–87 MU10

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08588008909041

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.

Y060308LUMBOSACRAL SPINE ORTHOSES

Critical warnings

8 warnings recorded — scroll inside the panel to see all entries.

The device is not intended for use by children, or adolescents and pregnant women.
OTHER
Remove the orthopedic lumbar belt BackieBelt at night.
OTHER
Regularly inspect the device for signs of damage or wear (e.g., torn straps, weakened fasteners). Discontinue use if the device integrity is compromised, as it may not provide adequate support.
OTHER
The BackieBelt orthopedic lumbar belt is not intended to be worn directly on bare skin. It is recommended to wear it over a layer of thin clothing to minimize the risk of skin irritation and ensure comfort.
OTHER
Consult healthcare professional before use
Consult a healthcare professional before using the device, specifically if you have underlying conditions, such as (but not limited to): o Osteoporosis o Herniated discs o Severe spinal deformities or injuries requiring rigid immobilization
Users with cognitive or physical impairments should only use the device under supervision to ensure correct application and adjustment.
OTHER
The device is not a substitute for proper lifting techniques, or physical rehabilitation.
OTHER
Consult instructions for use
Ensure the device is applied and adjusted according to the Instructions for Use. Improper fitting or excessive tightening may lead to discomfort, restricted movement, or compromised circulation

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Slovakia; available across 1 country total.

Country	On market since	Until
SlovakiaPrimary placement	—	Still on market

BackieBelt

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

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

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Market distribution

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Manufacturer information

Certificates covering this device

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Certificates