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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

WENTU01K — Class IIa MDR by Aflofarm Farmacja…

MD Atlas
Aflofarm Farmacja Polska Sp. z o.o.

EUDAMED last updated this device on Jan 9, 2025

WENTU01K

590280270019AW

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Aflofarm Farmacja Polska Sp. z o.o.
UDI-DI code: 05906071003115
Reference / catalog number: WENTU01K

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View device family (Basic UDI)

Manufacturer information

Organization name: Aflofarm Farmacja Polska Sp. z o.o.
SRN: PL-MF-000001809
Manufacturer status: Active

Related devices

N/A590280270026ATOn the market WENTO01K590280270020AFOn the market WREVA01K590280270020AFOn the market

Certificates

Certificate health across this manufacturer's portfolio.

TNP/MDR/0028/2720/2024Issued
Quality management systemNotified body: 2274Expiry: Dec 16, 2027
1434-MDR-024/2024Issued
Quality management systemNotified body: 1434Expiry: Dec 11, 2029
1434-MDR-025/2024Issued
Technical documentationNotified body: 1434Expiry: Dec 11, 2029

Critical warnings

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

CW011
Consult instructions for use; Do not use past indicated date; Keep out of reach of children

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Market distribution

Primary placement in Poland; available across 1 country total.

Country	On market since	Until
PolandPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 05906071003115
Basic UDI-DI: 590280270019AW
Reference / catalog number: WENTU01K
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 8
Additional product description: Osmotic hydrogel intended for administration on the skin
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)05906071003115

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

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

M9002PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)

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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