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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

600521 — Class IIa MDR by KiiltoClean Oy

MD Atlas
KiiltoClean Oy

EUDAMED last updated this device on Sep 5, 2022

600521

6417964MDL000070607H

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: KiiltoClean Oy
UDI-DI code: 07054956005216
Reference / catalog number: 600521

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Manufacturer information

Organization name: KiiltoClean Oy
SRN: FI-MF-000001622
Manufacturer status: Active

Critical warnings

6 warnings recorded — scroll inside the panel to see all entries.

CW057
EUDAMED did not publish a description for this code.
CW085
EUDAMED did not publish a description for this code.
CW139
EUDAMED did not publish a description for this code.
CW148
EUDAMED did not publish a description for this code.
CW416
EUDAMED did not publish a description for this code.
CW397
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Norway; available across 1 country total.

Country	On market since	Until
NorwayPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 07054956005216
Basic UDI-DI: 6417964MDL000070607H
Reference / catalog number: 600521
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

D0701ETHANOL FOR THE DISINFECTION OF MEDICAL DEVICES

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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

82806417964MDL031016248ZOn the market 80846417964MDL031016248ZOn the market 803876417964MDL031016248ZOn the market 6012806417964MDL000070607HOn the market 6030036417964MDL000070407BOn 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.