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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

RectalPro75 — Class I MDR by QLRAD international Ltd

MD Atlas
QLRAD international Ltd

EUDAMED last updated this device on May 28, 2026

RectalPro75

87193262582105.1018RU

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: QLRAD international Ltd
UDI-DI code: 08719326258263
Reference / catalog number: 105.1018

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View device family (Basic UDI)

Manufacturer information

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

Critical warnings

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

CW138
read IFU first

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Market distribution

Primary placement in Netherlands; available across 1 country total.

Country	On market since	Until
NetherlandsPrimary placement	Jan 1, 2020	May 28, 2026

Device identification

Trade name: RectalPro75
UDI-DI code: 08719326258263
Basic UDI-DI: 87193262582105.1018RU
Reference / catalog number: 105.1018
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: rectal ballon for immobilization
Additional information URL: https://www.qlrad.com/
Clinical sizes: 0.11–0.13 MU10

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08719326258263

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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.

V0804PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)

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

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.