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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

FLIP4.0 — Class IIb MDD by Humedics GmbH

MD Atlas
Humedics GmbH

EUDAMED last updated this device on Jun 29, 2023

FLIP4.0

B-MDD-FLIP4.0Z8

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Humedics GmbH
UDI-DI code: D-MDD-FLIP4.0Z8
Reference / catalog number: FLIP4.0

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Manufacturer information

Organization name: Humedics GmbH
SRN: DE-MF-000005094
Manufacturer status: Active

Critical warnings

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

CW011
Do not apply the LiMAx test to patients with known allergic reactions to methacetin or paracetamol.

Market distribution

Primary placement in Germany; available across 3 countries total.

Country	On market since	Until
GermanyPrimary placement		Still on market
Austria		Still on market
Bulgaria		Still on market

Device identification

Trade name: not provided
UDI-DI code: D-MDD-FLIP4.0Z8
Basic UDI-DI: B-MDD-FLIP4.0Z8
Reference / catalog number: FLIP4.0
Issuing entity: EUDAMED

Classification

Risk category: Class IIb
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)

Z12040103HEPATIC FUNCTIONALITY EQUIPMENT

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.