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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

REF 801 — Class I MDR by Lang-Stereotest AG

MD Atlas
Lang-Stereotest AG

EUDAMED last updated this device on Apr 15, 2026

REF 801

7649996943002KU

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Lang-Stereotest AG
UDI-DI code: 07649996943071
Reference / catalog number: REF 801

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Manufacturer information

Organization name: Lang-Stereotest AG
SRN: CH-MF-000029998
Manufacturer status: Active

Market distribution

Primary placement in Austria; available across 1 country total.

Country	On market since	Until
AustriaPrimary placement	Aug 16, 2021	Still on market

Device identification

Trade name: not provided
UDI-DI code: 07649996943071
Basic UDI-DI: 7649996943002KU
Reference / catalog number: REF 801
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)

Q0209STRABISMUS DEVICES

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

Related devices

REF 8027649996943002KUOn the market REF 9017649996943002KUOn the market REF 5017649996943002KUOn the market REF 1037649996943002KUOn the market REF 1047649996943002KUOn 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.