Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Partners 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

SensiScreen — IVDD — General IVDD by PentaBase A/S

MD Atlas
PentaBase A/S

EUDAMED last updated this device on May 25, 2022

SensiScreen

B-5713915SS004V9QS

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: PentaBase A/S
UDI-DI code: D-5713915SS004V9QS
Reference / catalog number: 5675;5686;5550;5366;5575;5391;5545;5361;5555;5371;5540;5351;5570;5386;5560;5376;5565;5381;3075;5408

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?

View device family (Basic UDI)

Manufacturer information

Organization name: PentaBase A/S
SRN: DK-MF-000023157
Manufacturer status: Active

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

1 warning recorded — scroll inside the panel to see all entries.

CW009
The buffers, primer/probe, and tubes are not to be reused.

EasyUDICompliance engine

Sponsored

Your devices, UDI-compliant — without drowning in regulation

EUDAMED-ready· UDI-enriched

Basic UDIUDI-DIUDI-PIAttributeDocument

Print-ready label

From your product file — no manual entry

Exclusive to MD Atlas usersClaim my −20% discount

by Made In Tracker

Market distribution

Primary placement in Denmark; available across 1 country total.

Placed on the market in Denmark; per-country availability dates not published.

Device identification

Trade name: SensiScreen
UDI-DI code: D-5713915SS004V9QS
Basic UDI-DI: B-5713915SS004V9QS
Reference / catalog number: 5675;5686;5550;5366;5575;5391;5545;5361;5555;5371;5540;5351;5570;5386;5560;5376;5565;5381;3075;5408
Issuing entity: EUDAMED

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: SensiScreen® Liquid EGFR qPCR Assay is a semi-quantitative real-time Polymerase Chain Reaction (PCR) assay intended for the detection, identification, and relative quantification of specific somatic mutations in the human Epidermal Growth Factor Receptor (EGFR) gene in cell-free DNA (cfDNA) purified from liquid biopsies including blood and plasma. The assay is used with real-time PCR systems and samples can be prepared using automated platforms or in manual workflows. The assay is an in vitro diagnostic medical device intended to aid in the detection, identification, monitoring of disease progression, and re-appearance based on EGFR mutation status. The test result correlates with the amount of EGFR mutant cfDNA. Result can be used to determine changes in EGFR mutation quantity levels in patients over time such as during cancer interventions and as an aid in selecting proper treatment of cancer. SensiScreen® Liquid EGFR qPCR Assay is intended to be used by healthcare professionals or qualified laboratory personnel instructed and trained in the techniques of real-time PCR as well as proficient in handling biological samples. Medical interventions based on results from this product requires medical authorization.
Additional information URL: https://www.5ba.se/SS004
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

D-5713915SS004V9QS

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

EMDN nomenclature code(s)

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

W01060299TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Related devices

BasePurifier5713915BP003NPOn the market BasePurifier5713915BP002NMOn the market BasePurifier5713915BP001NKOn the market BaseSNAP™ Sensitive Nucleic Acid Purification Kit5713915BS001P8On the market BaseSNAP™ Sensitive Nucleic Acid Purification Kit5713915BS001P8

On the market

Become a partner of MD Atlas