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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

21-301049 — Class IIb MDD by Biomedica, spol. s.r.o

MD Atlas
Biomedica, spol. s.r.o

EUDAMED last updated this device on Jan 30, 2026

21-301049

B-02500EM

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Biomedica, spol. s.r.o
UDI-DI code: D-02500EM
Reference / catalog number: 21-301049

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Manufacturer information

Organization name: Biomedica, spol. s.r.o
SRN: CZ-MF-000007412
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Czechia; available across 2 countries total.

Country	On market since	Until
CzechiaPrimary placement	Jan 1, 2014	Jan 30, 2026
Germany	Jan 1, 2014	Jan 30, 2026

Device identification

Trade name: not provided
UDI-DI code: D-02500EM
Basic UDI-DI: B-02500EM
Reference / catalog number: 21-301049
Issuing entity: EUDAMED

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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

F0499DIALYSIS CONCENTRATES - OTHER

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

This device is not currently linked to any other device.

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.