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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

610221 — Class I MDR by Betterguards Technology…

MD Atlas
Betterguards Technology GmbH

EUDAMED last updated this device on Apr 28, 2026

610221

426235269TBGHH

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Betterguards Technology GmbH
UDI-DI code: 04262352693330
Reference / catalog number: 610221

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Manufacturer information

Organization name: Betterguards Technology GmbH
SRN: DE-MF-000028712
Manufacturer status: Active

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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.

Critical warnings

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

CW999
Anatomical conditions that prevent correct application; Lymph drainage disorders; Arterio-vascular disorders; Post-thrombotic conditions; Skin disease or skin irritation; Acute injuries or open wounds in ankle/foot area; Severe sensory disturbances; Polyneuropathy (e.g. diabetes mellitus); Post-traumatic/postoperative acute care. Caution: Before EVERY use, check mini-piston functionality. Do not use if defective.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 04262352693330
Basic UDI-DI: 426235269TBGHH
Reference / catalog number: 610221
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: 20.5–23.5 MU10

EMDN nomenclature code(s)

Y061299LOWER EXTREMITY ORTHOSES - 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