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Organization name
UDI-DI code
Reference / catalog number

DETTO-5000 — Class I MDR by Febromed GmbH & Co. KG

MD Atlas
Febromed GmbH & Co. KG

EUDAMED last updated this device on Mar 6, 2024

DETTO-5000

426074055TRACAX

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Febromed GmbH & Co. KG
UDI-DI code: 04260740550128
Reference / catalog number: DETTO-5000

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Manufacturer information

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

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CP426074055TUBHCOn the market DGH - ALU426074055TRACAXOn the market DGH426074055TRACAXOn the market PBall-55426074055TRACAXOn the market PBall-65426074055TRACAXOn 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.

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 Duoetto 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: 04260740550128
Basic UDI-DI: 426074055TRACAX
Reference / catalog number: DETTO-5000
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: Gebärsystem: an dem, bei der Einleitung einer Geburt Entspannungsübungen vorgenommen werden können, sowohl auf dem die Geburt stattfinden kann.
Additional information URL: https://www.febromed.de/duoetto%e2%80%a8/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V080299MEDICAL CHAIRS - OTHER
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