Data from EUDAMED, last updated Jun 11, 2026

Reaction sample well

697454156014L4

10 references

IVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk category: IVDR Class A
Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd

Device family identification

Device name: Reaction sample well
Basic UDI-DI: 697454156014L4
Device model: BTK-8-B10-10-00, BTK-8-B8-10-00, BTK-8-B4-10-00, BTK-8-B4-20-00, BTK-E04-B1-20-00, BTK-E04-B1-25-00, BTK-E04-B1-30-00, BTK-E04-B1-40-00, BTK-E02-B48-20-00, BTK-E02-B48-25-00"
Issuing agency: GS1
Version date: May 15, 2026

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

No device characteristics flagged

European Medical Device Nomenclature — the EU product classifications carried across this device family's references.

References

10 references

Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
BTK-E04-B1-30-00	`BTK-E04-B1-30-00`	`06974541565325`	1	On the market
BTK-8-B4-20-00	`BTK-8-B4-20-00`	`06974541565295`	1	On the market
BTK-8-B8-10-00	`BTK-8-B8-10-00`	`06974541565271`	1	On the market
BTK-E04-B1-25-00	`BTK-E04-B1-25-00`	`06974541565318`	1	On the market
BTK-E02-B48-25-00	`BTK-E02-B48-25-00`	`06974541565356`	1	On the market
BTK-E04-B1-40-00	`BTK-E04-B1-40-00`	`06974541565332`	1	On the market
BTK-E02-B48-20-00	`BTK-E02-B48-20-00`	`06974541565349`	1	On the market
BTK-8-B4-10-00	`BTK-8-B4-10-00`	`06974541565288`	1	On the market
BTK-E04-B1-20-00	`BTK-E04-B1-20-00`	`06974541565301`	1	On the market
BTK-8-B10-10-00	`BTK-8-B10-10-00`	`06974541565264`	1	On the market