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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

ZA0601 — IVDR Class A IVDR by R-Biopharm AG

MD Atlas
R-Biopharm AG

EUDAMED last updated this device on May 18, 2022

ZA0601

4049095ZA06010000JB

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: R-Biopharm AG
UDI-DI code: 04049095260049
Reference / catalog number: ZA0601

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Manufacturer information

Organization name: R-Biopharm AG
SRN: DE-MF-000007993
Manufacturer status: Active

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Critical warnings

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

CW999
for warnings and precautions see IFU

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: 04049095260049
Basic UDI-DI: 4049095ZA06010000JB
Reference / catalog number: ZA0601
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: Für die in-vitro Diagnostik. Der RIDA® CCD-lnhibitor ist ein Zubehör für RIDA® qLine Allergy Tests zur Blockierung von anti-CCD-lgE in humanem Serum und Plasma (Citrat). Das Produkt weist keine Erkrankung nach; es dient der Probenvorbereitung. Das Produkt ist für die professionelle Anwendung vorgesehen.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01010299SUBSTRATES - OTHER

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

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.