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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

PR101 — Class I MDR by Practomed UG

MD Atlas
Practomed UG

EUDAMED last updated this device on May 18, 2026

PR101

PP05394KG65

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Practomed UG
UDI-DI code: 110012371943
Reference / catalog number: PR101

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Manufacturer information

Organization name: Practomed UG
SRN: DE-MF-000013189
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW262
EUDAMED did not publish a description for this code.
CW999
Kontraindikationen: Bei akuten Bauch- und Unterleibserkrankungen (bei Bauchschmerzen und Erbrechen mit unklarer Ursache), Verletzungen im Bereich des Afters.
CW999
Warnhinweise und Vorsichtsmaßnahmen: Nur sauberes Wasser verwenden. Gleitmittel auf die Spitze des Darmrohrs auftragen, um mechanische Irritationen des Analkanals zu vermeiden. Bei Widerstand oder Schmerzen bei der Einführung des Darmrohrs den Vorgang abbrechen und einen Arzt konsultieren.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Jan 27, 2007	Still on market

Device identification

Trade name: not provided
UDI-DI code: 110012371943
Basic UDI-DI: PP05394KG65
Reference / catalog number: PR101
Issuing entity: IFA

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)

G020301RECTAL TUBES

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

Related devices

PR104PP05394KG65On the market PR102PP05394KG65On the market PR105PP05394KG65On the market PR103PP05394KG65On the market PR106PP05394KG65On 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.