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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

60004 — Class I MDR by Tjugohundra18 AB

MD Atlas
Tjugohundra18 AB

EUDAMED last updated this device on Mar 25, 2026

60004

734018576000401F2

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Tjugohundra18 AB
UDI-DI code: 07340185700511
Reference / catalog number: 60004

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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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Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Sweden; available across 1 country total.

Placed on the market in Sweden; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 07340185700511
Basic UDI-DI: 734018576000401F2
Reference / catalog number: 60004
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: Lakansskyddet är av högabsorberande material med ett spärrskikt som ”andas” kroppsvärmen, men är ändå helt vätsketätt. Skyddet är laminerat vilket gör det starkt och resulterar även i en slät bäddyta, vilket minskar risk för t.ex. trycksår. Lakansskyddet är färgkodat för att brukare/personal lätt ska kunna avgöra vilken sida som ska vara upp respektive ner i sängen (anvisning finns på tvättlapp). Lakansskyddet har bäddflikar som bäddas under madrassen och gör att skyddet ligger på plats i sängen. Produkten innehåller ingen PVC eller Latex.
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.

T0499INCONTINENCE 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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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.