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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

Knee Brace — Class I MDR by Burman Enterprise

MD Atlas
Burman Enterprise

EUDAMED last updated this device on Jul 23, 2025

Knee Brace

819504020014BG

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Burman Enterprise
UDI-DI code: 00819504020014
Reference / catalog number: Knee Brace

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View device family (Basic UDI)

Manufacturer information

Organization name: Burman Enterprise
SRN: SE-MF-000048669
Manufacturer status: Active

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Patella Strap819504020021BDOn the market Elbow Sleeve819504020243BZOn the market B09LLX9XNY819504020717CROn the market Knee Sleeve with Strap819504020359CMOn the market B0C3LLBGM2819504020717CROn the market

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.

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Sweden; available across 1 country total.

Placed on the market in Sweden; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 00819504020014
Basic UDI-DI: 819504020014BG
Reference / catalog number: Knee Brace
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: 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

EMDN nomenclature code(s)

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

Y061209KNEE 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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