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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

Skin fold Breast Wedge — Class I MDR by QLRAD international Ltd

MD Atlas
QLRAD international Ltd

EUDAMED last updated this device on May 22, 2026

Skin fold Breast Wedge

87193262582105.2000RG

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: QLRAD international Ltd
UDI-DI code: 08720892233004
Reference / catalog number: 105.2000

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View device family (Basic UDI)

Manufacturer information

Organization name: QLRAD international Ltd
SRN: NL-MF-000012167
Manufacturer status: Active

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RectalPro7587193262582105.1014RLOn the market RectalPro7587193262582105.1001RBOn the market RectalPro7587193262582105.1018RUOn the market Skin fold Breast Wedge87193262582105.3000RPOn the market

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.

Critical warnings

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

CW138
Do not use when wet, use only one device per patient

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Market distribution

Primary placement in Netherlands; available across 1 country total.

Country	On market since	Until
NetherlandsPrimary placement	Mar 26, 2025	May 22, 2026

Device identification

Trade name: Skin fold Breast Wedge
UDI-DI code: 08720892233004
Basic UDI-DI: 87193262582105.2000RG
Reference / catalog number: 105.2000
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: Wedge to put barrier in between skin folds during radiation to prevent breakdown skin and or to create distance to reduce radiation to other not targeted body parts
Additional information URL: https://www.qlrad.com/
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)08720892233004

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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.

T030499RADIOTHERAPY PROTECTION DEVICES - 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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