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Organization name
UDI-DI code
Reference / catalog number

VARIOD-7950 — Class I MDR by Febromed GmbH & Co. KG

MD Atlas
Febromed GmbH & Co. KG

EUDAMED last updated this device on Aug 9, 2023

VARIOD-7950

426074055TRACAX

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Febromed GmbH & Co. KG
UDI-DI code: 04260740550166
Reference / catalog number: VARIOD-7950

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Manufacturer information

Organization name: Febromed GmbH & Co. KG
SRN: DE-MF-000009287
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.

Critical warnings

3 warnings recorded — scroll inside the panel to see all entries.

CW010
Healthcare professional must read the instructional manuel completely before use the get up for the first time.
CW030
Do not use without a healthcare professional
CW011
Material damaged by overload

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: 04260740550166
Basic UDI-DI: 426074055TRACAX
Reference / catalog number: VARIOD-7950
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: Haltesystem: An dem, bei der Einleitung einer Geburt, Entspannungsübungen vorgenommen werden können. Sowie bei der Geburt die Gebärende sich festhalten kann.
Additional information URL: https://www.febromed.de/variotrac%e2%80%a8/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V0899MEDICAL SUPPORT EQUIPMENT - 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