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

701119213 — Class IIb MDD by Biochem Bernburg GmbH

MD Atlas
Biochem Bernburg GmbH

EUDAMED last updated this device on Jul 14, 2023

701119213

B-04260361560681

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Biochem Bernburg GmbH
UDI-DI code: 04260361560681
Reference / catalog number: 701119213

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: Biochem Bernburg GmbH
SRN: DE-MF-000036372
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Sep 27, 2018	Sep 26, 2023

Device identification

Trade name: not provided
UDI-DI code: 04260361560681
Basic UDI-DI: B-04260361560681
Reference / catalog number: 701119213
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: trockenes Salzkonzentrat
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: Mischung verschiedener Salze

EMDN nomenclature code(s)

F040201DIALYSIS CONCENTRATES, BASIC SOLUTIONS, POWDER

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

3104 20 90-5B-04260361560735On the market 71000928B-04260361560414On the market 71000882B-04260361560285On the market 71000850B-04260361560162On the market 71000820B-04260361560018On 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.