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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

P1B-24-20 — IVDR Class A IVDR by Gesellschaft zur…

MD Atlas
Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH

EUDAMED last updated this device on Sep 11, 2023

P1B-24-20

42623533712M2

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH
UDI-DI code: 04262353370018
Reference / catalog number: P1B-24-20

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Manufacturer information

Organization name: Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH
SRN: DE-MF-000025295
Manufacturer status: Active

Related devices

P2E-28-30B-04262353370070On the market P1A-24-0442623533711LYOn the market P2D-28-30B-04262353370063On the market P2B-28-30B-04262353370049On the market P2A-28-30B-04262353370032On the market

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

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

CW265
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 04262353370018
Basic UDI-DI: 42623533712M2
Reference / catalog number: P1B-24-20
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Reagent kit to support the PoET Extraction Kit
Additional information URL: https://www.gfeblut.de/media/eifu/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0105900101REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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