Identity
- Trade Name
- IZOTERMICKÁ FÓLIE EUDAMED
- Device Name
- Isothermic foil EUDAMED
- Model / Reference
- 16064 EUDAMED16070 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18590317160645 EUDAMED18590317160706 EUDAMED
- Basic UDI-DI
- 85903170002SH EUDAMED
- EMDN Code
- T030399 HEATING COVERS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Izotermická Fólie by BIOSTER, a.s. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 85903170002SH | Class I | Active |
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Manufacturer
- Manufacturer
- BIOSTER, a.s.
- EUDAMED SRN
- CZ-MF-000011615
Sources (2)
- EUDAMED 77a7a868-d2da-44a4-bbb9-4ca65e0b2f85 61 fields · synced Jul 30, 2026
- EUDAMED 1f558f63-a403-4af3-b8e3-7aef134da64b 61 fields · synced May 18, 2026