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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

2828 20 00-9 — Class IIb MDD by Biochem Bernburg GmbH

MD Atlas
Biochem Bernburg GmbH

EUDAMED last updated this device on Jul 14, 2023

2828 20 00-9

B-04260361560766

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Biochem Bernburg GmbH
UDI-DI code: 04260361560766
Reference / catalog number: 2828 20 00-9

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Manufacturer information

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

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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.

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: 04260361560766
Basic UDI-DI: B-04260361560766
Reference / catalog number: 2828 20 00-9
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: Salzlösung
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: Mischung verschiedener Salzlösungen

EMDN nomenclature code(s)

F040101DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE

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

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