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Organization name
UDI-DI code
Reference / catalog number

T117 — IVDR Class A IVDR by Tammer BioLab Oy

MD Atlas
Tammer BioLab Oy

EUDAMED last updated this device on May 30, 2022

T117

643008010T117XQ

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Tammer BioLab Oy
UDI-DI code: 06430080100323
Reference / catalog number: T117

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Manufacturer information

Organization name: Tammer BioLab Oy
SRN: FI-MF-000010901
Manufacturer status: Active

Critical warnings

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

CW009
EUDAMED did not publish a description for this code.
CW007
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.

Placed on the market in Finland; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 06430080100323
Basic UDI-DI: 643008010T117XQ
Reference / catalog number: T117
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Selektiivinen elatusainemalja homeiden ja hiivojen kasvatukseen infektioiden havaitsemiseksi [FI]
Additional information URL: https://portal.tammerbiolab.fi/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0104030201PPM FOR YEASTS AND FUNGI

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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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.