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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

15060 — Class I MDR by Tjugohundra18 AB

MD Atlas
Tjugohundra18 AB

EUDAMED last updated this device on Feb 25, 2026

15060

734018571506001F4

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Tjugohundra18 AB
UDI-DI code: 07340185700092
Reference / catalog number: 15060

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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.

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

Device identification

Trade name: not provided
UDI-DI code: 07340185700092
Basic UDI-DI: 734018571506001F4
Reference / catalog number: 15060
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: ProSense Antikvalster Kuddskydd Maria är ett örngott som kan användas vid kvalsterallergi. Kvalsterskyddet kan användas som överdrag på din huvudkudde för att inte släppa igenom allergipartiklar. Kuddskyddet är gjort av materialet Evolon som ger ett skyddande skikt mot allergener från kvalster. Filteringsförmågan hos Evolon-tyget beror på den täta och kompakta strukturen. ProSense rekommenderar att du använder kvalsterskyddet och ett vanligt örngott. ProSense kuddskydd har en lyxig känsla och är av hög kvalitet. Materialet Evolon har OEKO-TEX standard 100 klass 1. Materialet är certiferat av ECARF (European Center for Allergy Research Fondation) Mått: 60 x 50 cm
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.

V0899MEDICAL SUPPORT EQUIPMENT - 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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