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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

Fastidious anaerobe agar (FAA)… — IVDR Class A IVDR

MD Atlas
Tammer BioLab Oy

EUDAMED last updated this device on Jul 4, 2025

Fastidious anaerobe agar (FAA) resistance plate with horse blood

643008010T326Y3

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: 06430080102242
Reference / catalog number: T326

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Manufacturer information

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

Critical warnings

4 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.
CW267
Animal blood

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: Fastidious anaerobe agar (FAA) resistance plate with horse blood
UDI-DI code: 06430080102242
Basic UDI-DI: 643008010T326Y3
Reference / catalog number: T326
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: Nutrient-rich ready-to-use plate for antibiotic susceptibility testing of rapidly growing anaerobic bacteria
Additional information URL: https://portal.tammerbiolab.fi/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0104010403SUSCEPTIBILITY TEST MEDIA (PLATES)

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.