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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

601280 — Class IIa MDR by KiiltoClean Oy

MD Atlas
KiiltoClean Oy

EUDAMED last updated this device on Sep 5, 2022

601280

6417964MDL000070607H

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: KiiltoClean Oy
UDI-DI code: 07054956012801
Reference / catalog number: 601280

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Manufacturer information

Organization name: KiiltoClean Oy
SRN: FI-MF-000001622
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

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: 07054956012801
Basic UDI-DI: 6417964MDL000070607H
Reference / catalog number: 601280
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