Identity
- Trade Name
- EBV-NEO EUDAMED
- Device Name
- Biovak EUDAMED
- Model / Reference
- EBV-NEO EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08594206470283 EUDAMED
- Basic UDI-DI
- 859420647F01EBV6L EUDAMED
- Direct Marketing DI
- 08594206470283 EUDAMED
- EMDN Code
- T030599 HEALTH SERVICE PREMISES PROTECTION DEVICES - 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
Ebv-Neo by EGO Zlín, spol. s r.o. — 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 | 859420647F01EBV6L | Class I | Active |
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Manufacturer
- Manufacturer
- EGO Zlín, spol. s r.o.
- EUDAMED SRN
- CZ-MF-000031911
Sources (1)
- EUDAMED 4e1ecd57-3bef-450b-9fe3-c355ea8f18c2 61 fields · synced Jun 18, 2026