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Organization name
UDI-DI code
Reference / catalog number

ISOTHERMIC FOIL — Class I MDR by BIOSTER, a.s.

MD Atlas
BIOSTER, a.s.

EUDAMED last updated this device on Apr 28, 2026

ISOTHERMIC FOIL

85903170002SH

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: BIOSTER, a.s.
UDI-DI code: 18590317160645
Reference / catalog number: 16064

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Manufacturer information

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

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Critical warnings

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

CW009
EUDAMED did not publish a description for this code.
CW038
EUDAMED did not publish a description for this code.
CW999
Chráňte pred poškodením ostrými predmetmi!
CW999
Protect from damage caused by sharp objects!
CW999
Chráňte před poškozením ostřými predměty!
CW999
Nepoužívajte v bezprostrednej blízkosti ohňa!
CW999
Do not use in immediate proximity of fire!
CW999
Nepoužívejte v bezprostřední blízkosti ohně!

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: ISOTHERMIC FOIL
UDI-DI code: 18590317160645
Basic UDI-DI: 85903170002SH
Reference / catalog number: 16064
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 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: silver/silver
1400 x 2200

EMDN nomenclature code(s)

T030399HEATING COVERS - 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

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