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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

BW01-M-53 — Class I MDR by Optik Sutter e.U.

MD Atlas
Optik Sutter e.U.

EUDAMED last updated this device on Mar 27, 2026

BW01-M-53

912014381BWOS014W

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Optik Sutter e.U.
UDI-DI code: 09120143810098
Reference / catalog number: BW01-M-53

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Manufacturer information

Organization name: Optik Sutter e.U.
SRN: AT-MF-000052724
Manufacturer status: Active

Market distribution

Primary placement in Austria; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 09120143810098
Basic UDI-DI: 912014381BWOS014W
Reference / catalog number: BW01-M-53
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: Brillenfassung aus Kunststoff (3D-Druck), Scheibenbreite 53mm
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 53 MU50

EMDN nomenclature code(s)

Q02100202PLASTIC SPECTACLE FRAMES WITHOUT LENSES

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

BW01-M-58912014381BWOS014WOn the market BW01-M-55912014381BWOS014WOn the market BW01-M-57912014381BWOS014WOn the market BW01-M-54912014381BWOS014WOn the market BW01-M-52912014381BWOS014WOn 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.