Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ 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

Z1000 — IVDR Class A IVDR by R-Biopharm AG

MD Atlas
R-Biopharm AG

EUDAMED last updated this device on May 24, 2022

Z1000

4049095Z1000000003Z

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: 04049095260001
Reference / catalog number: Z1000

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?

Manufacturer information

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

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: 04049095260001
Basic UDI-DI: 4049095Z1000000003Z
Reference / catalog number: Z1000
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: 100
Additional product description: For in vitro diagnostic use. The RIDA® Anreicherungsbouillon is used for the enrichment of bacteria that produce verotoxin 1 and verotoxin 2 (synonyms: Shiga toxin 1 and Shiga toxin 2) and for inducing the production of those toxins in untreated human stool samples from people with symptoms of gastroenteritis. The RIDA® Anreicherungsbouillon is used for sample preparation and is intended for use with the RIDASCREEN® Verotoxin kit. The product is intended for professional use.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0104010206MEDIA IN TUBES (SOLID & LIQUID)

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

Related devices

UN00104049095UN00100000KZOn the market A85924049095A859200000SUOn the market A85924049095A859200000SUOn the market CRP13044049095C130100000H9On the market C1301K02-VK4049095C130100000H9On 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.