Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

T113 — IVDR Class A IVDR by Tammer BioLab Oy

MD Atlas
Tammer BioLab Oy

EUDAMED last updated this device on May 30, 2022

T113

643008010T113XG

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: 06430080100286
Reference / catalog number: T113

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

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

Related devices

T007643008010T007XGOn the market T017643008010T017XKOn the market Chromogenic agar plate for carbapenemase prod. enterobacteria (CPE)B-06430080100552On the market Chromogenic agar plate for extended beta-lactamase producers (ESBL)B-06430080100538On the market Chromogenic agar plate for methicillin-resistant Staph. aureus (MRSA)B-06430080100453On 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.

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: 06430080100286
Basic UDI-DI: 643008010T113XG
Reference / catalog number: T113
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 valmismalja dermatofyyttien, hiivojen ja homeiden aiheuttamien infektioiden havaitsemiseen [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