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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

DibuCell ACTIVE ACTIVE DRESSING… — Class III MDD

MD Atlas
Celther Polska Sp. z o.o.

EUDAMED last updated this device on Jul 12, 2022

DibuCell ACTIVE ACTIVE DRESSING MATERIAL ACCELERATING WOUND HEALING

B-05905669556149

On the marketClass III

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Celther Polska Sp. z o.o.
UDI-DI code: 05905669556149
Reference / catalog number: DA

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View device family (Basic UDI)

Manufacturer information

Organization name: Celther Polska Sp. z o.o.
SRN: PL-MF-000002202
Manufacturer status: Active

Critical warnings

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

CW009
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Poland; available across 1 country total.

Country	On market since	Until
PolandPrimary placement	Sep 1, 2017	Aug 10, 2022

Device identification

Trade name: DibuCell ACTIVE ACTIVE DRESSING MATERIAL ACCELERATING WOUND HEALING
UDI-DI code: 05905669556149
Basic UDI-DI: B-05905669556149
Reference / catalog number: DA
Issuing entity: GS1

Classification

Risk category: Class III
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Opakowanie jedna sztuka, rozmiar 10x15cm
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)05905669556149

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

M040499DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - 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

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Related devices

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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.