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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

UNI SET OF 20 PIMPLE PATCH AA SM… — Class I MDR

MD Atlas
POLYFLAME EUROPE SAS

EUDAMED last updated this device on Mar 25, 2025

UNI SET OF 20 PIMPLE PATCH AA SM ASS-24

3661075FLCBYL

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: POLYFLAME EUROPE SAS
UDI-DI code: 03661075050115
Reference / catalog number: 40509394

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Manufacturer information

Organization name: POLYFLAME EUROPE SAS
SRN: FR-MF-000042860
Manufacturer status: Active

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Critical warnings

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

CW011
If the dressing irritates the skin, discontinue use.
CW030
Consult a dermatologist if irritation persists. Do not use in combination with medications or therapies.
CW135
EUDAMED did not publish a description for this code.
CW999
In case of excessive drying or cracking of the skin or if the skin has been exposed to excessive peeling or rubbing, do not use these plasters until the skin is healthy again.

Market distribution

Primary placement in France; available across 1 country total.

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

Device identification

Trade name: UNI SET OF 20 PIMPLE PATCH AA SM ASS-24
UDI-DI code: 03661075050115
Basic UDI-DI: 3661075FLCBYL
Reference / catalog number: 40509394
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: 20
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)

V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - 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

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.