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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

346 784 01 — Class I MDR by FF Fémfeldolgozó Zrt.

MD Atlas
FF Fémfeldolgozó Zrt.

EUDAMED last updated this device on Aug 14, 2023

346 784 01

599957265WSEI2U

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: FF Fémfeldolgozó Zrt.
UDI-DI code: 05999572650025
Reference / catalog number: 346 784 01

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Manufacturer information

Organization name: FF Fémfeldolgozó Zrt.
SRN: HU-MF-000016012
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW018
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 05999572650025
Basic UDI-DI: 599957265WSEI2U
Reference / catalog number: 346 784 01
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: The warming drawer unit WSE/I is intended for installation in cabinets (preferably MEGAprogress) or mobile functional trolleys (preferably MEGAdrive). The warming drawer unit WSE/I is not suitable for operation in an unmounted condition. The warming drawer unit WSE/I is suitable for warming and keeping warm saline or Ringer's solution in infusion bags and bottles.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 24–40 MU34

EMDN nomenclature code(s)

V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - 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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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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.