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Organization name
UDI-DI code
Reference / catalog number

dOFM Dermal Catheter — Class IIa MDR by JOANNEUM RESEARCH…

MD Atlas
JOANNEUM RESEARCH Forschungsgesellschaft mbH

EUDAMED last updated this device on Jul 17, 2024

dOFM Dermal Catheter

912012209DEA9T

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: JOANNEUM RESEARCH Forschungsgesellschaft mbH
UDI-DI code: 09120122090015
Reference / catalog number: DEA15005

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Manufacturer information

Organization name: JOANNEUM RESEARCH Forschungsgesellschaft mbH
SRN: AT-MF-000017155
Manufacturer status: Active

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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.

Market distribution

Primary placement in Austria; available across 2 countries total.

Country	On market since	Until
AustriaPrimary placement	Mar 1, 2023	Still on market
Germany	Mar 1, 2023	Still on market

Device identification

Trade name: dOFM Dermal Catheter
UDI-DI code: 09120122090015
Basic UDI-DI: 912012209DEA9T
Reference / catalog number: DEA15005
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Dermal Catheter to perform Openflow Microperfusion
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

A99DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER

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

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