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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

HK KUROMI GLIT BAND AIDS METAL BOX — Class I MDR

MD Atlas
POLYFLAME EUROPE SAS

EUDAMED last updated this device on Mar 25, 2025

HK KUROMI GLIT BAND AIDS METAL BOX

3661075BL037GE4

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: POLYFLAME EUROPE SAS
UDI-DI code: 03661075030223
Reference / catalog number: 40509584

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Manufacturer information

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

Critical warnings

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

CW011
WARNINGS. Do not use if package is damaged. Clean, disinfect, rinse and dry the wound and its surroundings carefully. Apply the dressing by smoothing the edges. Change the dressing at least twice a day.

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: HK KUROMI GLIT BAND AIDS METAL BOX
UDI-DI code: 03661075030223
Basic UDI-DI: 3661075BL037GE4
Reference / catalog number: 40509584
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: 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)

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

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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.