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Organization name
UDI-DI code
Reference / catalog number

60180 — Class III MDD by BIOSTER, a.s.

MD Atlas
BIOSTER, a.s.

EUDAMED last updated this device on Apr 29, 2026

60180

B-CZMF00001161560180LJ

On the marketClass III

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: BIOSTER, a.s.
UDI-DI code: D-CZMF00001161560180LJ
Reference / catalog number: 60180

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Manufacturer information

Organization name: BIOSTER, a.s.
SRN: CZ-MF-000011615
Manufacturer status: Active

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Critical warnings

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

CW007
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW001
EUDAMED did not publish a description for this code.
CW010
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		Still on market
Slovakia		Still on market

Device identification

Trade name: not provided
UDI-DI code: D-CZMF00001161560180LJ
Basic UDI-DI: B-CZMF00001161560180LJ
Reference / catalog number: 60180
Issuing entity: EUDAMED

Classification

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

Device details

Quantity: 1
Additional product description: harmonika
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 1 MU24

EMDN nomenclature code(s)

M040501POLYSACCHARIDE HAEMOSTATIC DRESSINGS

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

Certificates

Certificate health across this manufacturer's portfolio.

24 0145 QR/NBIssued
Quality management systemNotified body: 1023Expiry: Apr 28, 2029
24 0146 TD/NBIssued
Technical documentationNotified body: 1023Expiry: Apr 28, 2029