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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

Newfoundland — IVDD — Annex II List B IVDD by PRIMA Lab SA

MD Atlas
PRIMA Lab SA

EUDAMED last updated this device on Apr 17, 2026

Newfoundland

B-07640164860084

On the marketIVDD — Annex II List B

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: PRIMA Lab SA
UDI-DI code: 07640164860084
Reference / catalog number: 880080-1

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Manufacturer information

Organization name: PRIMA Lab SA
SRN: CH-MF-000034473
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Oct 9, 2023	Still on market

Device identification

Trade name: Newfoundland
UDI-DI code: 07640164860084
Basic UDI-DI: B-07640164860084
Reference / catalog number: 880080-1
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Self-test for the determination of the Prostate-Specific Antigen (PSA) in whole blood samples
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0102160202PSA - RT & POC

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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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.