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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

09120050100046 — Class I MDD by KOSAN PHARMA GmbH

MD Atlas
KOSAN PHARMA GmbH

EUDAMED last updated this device on Mar 30, 2026

09120050100046

B-09120050100046

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: KOSAN PHARMA GmbH
UDI-DI code: 09120050100046
Reference / catalog number: 09120050100046

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Manufacturer information

Organization name: KOSAN PHARMA GmbH
SRN: AT-MF-000038337
Manufacturer status: Active

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09120050105003B-09120050105003On the market 09120050105010B-09120050105010On the market 09120050100053B-09120050100053On the market 09120050100183B-09120050100183On the market 09120050100381B-09120050100381On the market

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 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: 09120050100046
Basic UDI-DI: B-09120050100046
Reference / catalog number: 09120050100046
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDD [Directive 93/42/EEC 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)

V9017ORAL ADMINISTRATION PREPARATIONS NOT INCLUDED IN OTHER CLASSES

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

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.