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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

3623 — Class I MDR by Lilleborg AS

MD Atlas
Lilleborg AS

EUDAMED last updated this device on Apr 5, 2022

3623

704611DEKORENULTRAAE

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Lilleborg AS
UDI-DI code: 07046110213193
Reference / catalog number: 3623

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View device family (Basic UDI)

Manufacturer information

Organization name: Lilleborg AS
SRN: NO-MF-000012956
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW041
CLP: H314: Causes severe skin burns and eye damage. H290: Corrosive to metals. Product not intended for use on humans. CLP warning and precautions on label and SDS.

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Market distribution

Primary placement in Norway; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 07046110213193
Basic UDI-DI: 704611DEKORENULTRAAE
Reference / catalog number: 3623
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: Strongly alkaline decontaminator cleaning agent for difficult dirt on medical reusable equipment such as urine bottles, buckets etc. Should not be used on aluminum. Ecolabelled with the Swan, without dye. Product is sold via retailers in 3x5l canisters, and mainly within the Norwegian market (that is part of EU/EEA).
Additional information URL: https://www.lilleborg.no/produkter/infeksjonskontroll/dekoren-ultra/
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)07046110213193

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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.

V0799PRODUCTS FOR CLEANING MEDICAL DEVICES NOT INCLUDED IN OTHER CLASSES - 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.