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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

3832 — Class I MDR by Lilleborg AS

MD Atlas
Lilleborg AS

EUDAMED last updated this device on Oct 19, 2022

3832

704611DEKORENTORRH6

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Lilleborg AS
UDI-DI code: 07046110220528
Reference / catalog number: 3832

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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. 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: 07046110220528
Basic UDI-DI: 704611DEKORENTORRH6
Reference / catalog number: 3832
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: Low-foaming, acidic rinse and desiccant for use in instrument washers and automatic bed washing machines. Ensures good results with all water qualities. For quicker drying. Ecolabelled with the Swan, and without dye. Product is sold via retailers in a 200l barrel, and more or less only within the Norwegian market (that is part of EU/EEA). [EN]
Additional information URL: https://www.lilleborg.no/produkter/infeksjonskontroll/medisinsk_utstyr/dekoren-torr-2/
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)07046110220528

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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.