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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

3481 — Class I MDR by Lilleborg AS

MD Atlas
Lilleborg AS

EUDAMED last updated this device on Apr 5, 2022

3481

704611DEKORENENZYM7P

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Lilleborg AS
UDI-DI code: 07046110207765
Reference / catalog number: 3481

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View device family (Basic UDI)

Manufacturer information

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

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3575704611DEKORENENZYM7POn the market 9308264B-07615400234943On the market 7584704611DEKORENMILDD9On the market 3774704611DEKORENSPESIALC6On the market 3423704611DEKORENSPESIALC6On 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

No critical warnings reported for this device.

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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: 07046110207765
Basic UDI-DI: 704611DEKORENENZYM7P
Reference / catalog number: 3481
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: Neutral special agent for cleaning medical equipment in instrument washers / washing decontaminators, for manual washing, ultrasonic baths and soaking. Enzymatic cleaner specially developed for the gentle cleaning of sensitive equipment and can be used on most pH-sensitive materials. Ecolabelled with the Swan, without dye. Sold via retailers in 3x5l canisters, mainly within the Norwegian market (that is a part of EU/EEA).
Additional information URL: https://www.lilleborg.no/produkter/infeksjonskontroll/dekoren-enzym/
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)07046110207765

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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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