Devyser Index Plate LB-A

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

Devyser Index Plate LB-A

UDI-DI code

07350040632048

Basic UDI-DI

7350040638R202RA

Reference / catalog number

8-R202

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

Devyser Index Plate LB-A is intended for use as an accessory only in conjunction with the following products: • Devyser Chimerism (8‑A107) • One Lambda™ Devyser Chimerism (8-R107) • One Lambda™ Devyser Accept cfDNA (8-R114) • Devyser CFTR (8-R101) • Devyser Thalassemia v2 (8-R117)

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