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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

BCFB-6 — Class I MDR by Hysalma GmbH

MD Atlas
Hysalma GmbH

EUDAMED last updated this device on Mar 23, 2022

BCFB-6

4016964PflasterNY

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Hysalma GmbH
UDI-DI code: 09010405000599
Reference / catalog number: BCFB-6

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Manufacturer information

Organization name: Hysalma GmbH
SRN: DE-MF-000004985
Manufacturer status: Active

Critical warnings

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

CW275
EUDAMED did not publish a description for this code.
CW011
Nur bei oberflächlichen Wunden anwenden. Nicht bei infizierten Wunden verwenden. Stechen Sie Blasen nicht auf, um das Risiko von Infektionen zu verringern.
CW030
Bei Diabetes oder schlechter Durchblutung Rücksprache mit Arzt halten.

Market distribution

Primary placement in Austria; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 09010405000599
Basic UDI-DI: 4016964PflasterNY
Reference / catalog number: BCFB-6
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: 6
Additional product description: Blasenpflaster schützen vor Druck und Reibung mit polsterndem Effekt, für diverse Anwendungsorte im Fußbereich und halten Schmutz und Nässe ab.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

M0599MEDICAL PLASTERS - 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

Related devices

BCBM-64016964PflasterNYOn the market FHEM-184016964InkontinenzGYOn the market JSED-304016964InkontinenzGYOn 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.