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Organization name
UDI-DI code
Reference / catalog number

PZN 19075087 — Class I MDR by PakuMed medical…

MD Atlas
PakuMed medical products GmbH

EUDAMED last updated this device on May 27, 2026

PZN 19075087

426014678ANOKRYOJE

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: PakuMed medical products GmbH
UDI-DI code: 04260146783021
Reference / catalog number: PZN 19075087

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View device family (Basic UDI)

Manufacturer information

Organization name: PakuMed medical products GmbH
SRN: DE-MF-000005123
Manufacturer status: Active

Related devices

PZN 7470157426014678ANOKRYOJEOn the market PZN 3941536426014678ANOKRYOJEOn 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.

CW011
If coolant (bluish coloring) leaks from the rod, please dispose of the product with normal household waste. There is no danger for users or patients in case of direct contact with the coolant.

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Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 04260146783021
Basic UDI-DI: 426014678ANOKRYOJE
Reference / catalog number: PZN 19075087
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 low temperature rod and dilator for the treatment of hemorrhoids and their complications.
Additional information URL: https://pakumed.de/wp-content/uploads/2024/01/IIc-Gebrauchsanweisung-Deutsch_Englisch_-Arabisch_Multi-Size-Rev.1.pdf
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)04260146783021

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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.

L06050199NON-ENDOSCOPIC UROLOGICAL DILATION INSTRUMENTS, REUSABLE - 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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