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Organization name
UDI-DI code
Reference / catalog number

Medikro® Ambi — Class I MDR by Medikro Oy

MD Atlas
Medikro Oy

EUDAMED last updated this device on Sep 27, 2022

Medikro® Ambi

6420099M9489LX

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Medikro Oy
UDI-DI code: 06420099000844
Reference / catalog number: M911

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Manufacturer information

Organization name: Medikro Oy
SRN: FI-MF-000011841
Manufacturer status: Active

Critical warnings

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

CW011
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Finland; available across 1 country total.

Country	On market since	Until
FinlandPrimary placement		Still on market

Device identification

Trade name: Medikro® Ambi
UDI-DI code: 06420099000844
Basic UDI-DI: 6420099M9489LX
Reference / catalog number: M911
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12150199SPIROMETRY INSTRUMENTS - 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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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Certificates

Certificate health across this manufacturer's portfolio.

CR-03-1056-876-25Supplemented
Quality management systemNotified body: 0537Expiry: May 9, 2030