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Organization name
UDI-DI code
Reference / catalog number

VHFL-01-2-LI — Class I MDR by OPED GmbH

MD Atlas
OPED GmbH

EUDAMED last updated this device on May 6, 2026

VHFL-01-2-LI

4046618Y0606VHFAZ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: OPED GmbH
UDI-DI code: 04046618073810
Reference / catalog number: VHFL-01-2-LI

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Manufacturer information

Organization name: OPED GmbH
SRN: DE-MF-000008286
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 2 countries total.

Country	On market since	Until
GermanyPrimary placement	Apr 25, 2025	Still on market
Poland	Apr 25, 2025	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04046618073810
Basic UDI-DI: 4046618Y0606VHFAZ
Reference / catalog number: VHFL-01-2-LI
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.

EMDN nomenclature code(s)

Y060606HAND 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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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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.