Identity
- Trade Name
- Sonografický gel VITA 500 ml. EUDAMED
- Device Name
- Sonografický gel VITA EUDAMED
- Model / Reference
- 0670 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08594027310096 EUDAMED
- Basic UDI-DI
- 859402731026H7 EUDAMED
- Direct Marketing DI
- 08594027310096 EUDAMED
- EMDN Code
- Z11049085 VARIOUS ULTRASOUND INSTRUMENTS - CONSUMABLES 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
Sonografický gel VITA 500 ml. by ALFA VITA, 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 | 859402731026H7 | Class I | Active |
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Manufacturer
- Manufacturer
- ALFA VITA, s.r.o.
- EUDAMED SRN
- CZ-MF-000051941
Sources (1)
- EUDAMED 3f5f34bc-9a1e-401d-8b0b-8409f893a6a6 61 fields · synced Jul 31, 2026