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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

Plum QuickFix Black Long — Class I MDR by Plum Safety ApS

MD Atlas
Plum Safety ApS

EUDAMED last updated this device on Jan 6, 2025

Plum QuickFix Black Long

5715205QFPLASTER01SS

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Plum Safety ApS
UDI-DI code: 05715205000407
Reference / catalog number: 5523

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View device family (Basic UDI)

Manufacturer information

Organization name: Plum Safety ApS
SRN: DK-MF-000008672
Manufacturer status: Active

Critical warnings

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

CW009
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 Denmark; available across 1 country total.

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

Device identification

Trade name: Plum QuickFix Black Long
UDI-DI code: 05715205000407
Basic UDI-DI: 5715205QFPLASTER01SS
Reference / catalog number: 5523
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: The Plum QuickFix Black is used as a mechanical barrier to protect the wound from contamination and trauma, the absorbent pad for absorption of blood and exudates.
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)05715205000407

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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.

M04010199ADHESIVE DRESSINGS, WITH ABSORBENT PAD - 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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Certificates

Certificate health across this manufacturer's portfolio.

C590336Issued
Quality management systemNotified body: 2460Expiry: Sep 18, 2030