Statistics for FDAB

13Total Devices

13Basic UDI-DIs

0Not destined for EU market

0Certificates

0Valid

0Expiring < 6 months

1Countries

Certificate health for FDAB

No certificates registered for this manufacturer.

Showing 1–13 of 13 devices.

Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
CanAg AFP EIA	`600-10`	`17350066140371`	1	On the market
CanAg CA125 EIA	`400-10`	`17350066140241`	1	On the market
CanAg CA15-3 EIA	`200-10`	`17350066140081`	1	On the market
CanAg CA19-9 EIA	`120-10`	`17350066140050`	1	On the market
CanAg CA242 EIA	`101-10`	`17350066140012`	1	On the market
CanAg CEA EIA	`401-10`	`17350066140289`	1	On the market
CanAg NSE EIA	`420-10`	`17350066140340`	1	On the market
CanAg ProGRP EIA	`220-10`	`17350066140159`	1	On the market
CanAg S100 EIA	`708-10`	`17350066140388`	1	On the market
CanAg SCC EIA	`800-10`	`17350066140401`	1	On the market
CanChek Tumor Marker Control	`107-20`	`17350066140036`	1	On the market
Lung Marker Control	`240-20`	`17350066140531`	1	On the market
Mesothelin Control	`360-20`	`17350066140524`	1	On the market

Devices placed in 1 country

EUDAMED update: May 4, 2026

SE-MF-000007811

Active

ISAKSSON Linnéa
(b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; (c) the post-market surveillance obligations are complied with in accordance with Article 10(9) (e) in the case of devices for performance studies intended to be used in the context of interventional clinical performance studies or other performance studies involving risks for the subjects, the statement referred to in Section 4.1 of Annex XIV is issued.
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EKSTRÖM Elin
(a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released (d) the reporting obligations referred to in Articles 82 to 86 are fulfilled;
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