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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

55001 — Class I MDR by Tjugohundra18 AB

MD Atlas
Tjugohundra18 AB

EUDAMED last updated this device on Apr 5, 2026

55001

734018575500103G7

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Tjugohundra18 AB
UDI-DI code: 07340185700313
Reference / catalog number: 55001

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View device family (Basic UDI)

Manufacturer information

Organization name: Tjugohundra18 AB
SRN: SE-MF-000003776
Manufacturer status: Active

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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.

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Sweden; available across 1 country total.

Country	On market since	Until
SwedenPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 07340185700313
Basic UDI-DI: 734018575500103G7
Reference / catalog number: 55001
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: 3
Additional product description: ProSense Benfixering för urinpåse är en fixeringsficka för urinpåse som passar alla urinuppsamlingspåsar på marknaden, både tömbara och slutna påsar. Fixeringspåsen passar för både vänster och höger ben, samt underben.
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

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Y0999PERSONAL CARE AIDS - 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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