Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

09120050103634 — Class I MDD by KOSAN PHARMA GmbH

MD Atlas
KOSAN PHARMA GmbH

EUDAMED last updated this device on Mar 27, 2026

09120050103634

B-09120050103634

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: KOSAN PHARMA GmbH
UDI-DI code: 09120050103634
Reference / catalog number: 09120050103634

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

Organization name: KOSAN PHARMA GmbH
SRN: AT-MF-000038337
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 Croatia; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 09120050103634
Basic UDI-DI: B-09120050103634
Reference / catalog number: 09120050103634
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

Related devices

09120050105003B-09120050105003On the market 09120050100046B-09120050100046On the market 09120050105010B-09120050105010On the market 09120050100053B-09120050100053On the market 09120050100183B-09120050100183On 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.