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

60181 — Class III MDD by BIOSTER, a.s.

MD Atlas
BIOSTER, a.s.

EUDAMED last updated this device on Apr 29, 2026

60181

B-CZMF00001161560181LL

On the marketClass III

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: BIOSTER, a.s.
UDI-DI code: D-CZMF00001161560181LL
Reference / catalog number: 60181

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

Related devices

1006085903170010SGOn the market 1006185903170010SGOn the market 1006285903170010SGOn the market 1006885903170010SGOn the market 1006785903170010SGOn the market

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-CZMF00001161560181LL
Basic UDI-DI: B-CZMF00001161560181LL
Reference / catalog number: 60181
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: 2 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