560 Sizer Orange

Organization name

Devyser AB

SRN

SE-MF-000001699

Manufacturer status

Active

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

• CW032

  EUDAMED did not publish a description for this code.
• CW010

  See individual product IFU where this accessory is used.

Primary placement in Sweden; available across 32 countries total.

Trade name

560 Sizer Orange

UDI-DI code

07350040632079

Basic UDI-DI

7350040638R402RL

Reference / catalog number

8-R402

Issuing entity

GS1

Risk category

IVDR Class A

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

560 SIZER ORANGE is intended for use as an accessory only in conjunction with the following products: • Devyser AZF v2 (8-A019.2) • Devyser AZF Extension (8-A020) • Devyser CFTR 68 (8-A045) • Devyser CFTR Core (8-A031) • Devyser CFTR Italia v2 (8-A032.2) • Devyser Compact (8-R017) • Devyser Compact v3 (8-A017.3) • Devyser Complete v2 (8-A011.2) • Devyser CVD (8-A036) • Devyser Extend v2 (8-A015.2) • Devyser Extend M1 v2 (8-A015.2-M1) • Devyser HFE v2 (8-A030.2) • Devyser Resolution v2 13/18/21/XY (8-A012.2) • Devyser Thrombophilia (8-A035)

Additional information URL

https://www.devyser.com/ifu

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W0106010499POLYMORPHISM TESTS - OTHER