Organization name

BIOSTER, a.s.

SRN

CZ-MF-000011615

Manufacturer status

Active

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.

Primary placement in Czechia; available across 19 countries total.

Trade name

Traumastem FAM Strata

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

18590317090126

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

85903170010SG

Reference / catalog number

9012

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class III

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

10

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 5 x 10 cm

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• M040501POLYSACCHARIDE HAEMOSTATIC DRESSINGS

• Class III medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.