Identity
- Trade Name
- VENTURA BITE 2.0 (2X50 ml) EUDAMED
- Device Name
- Ventura dental impression material EUDAMED
- Model / Reference
- 3396 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435316133968 EUDAMED
- Basic UDI-DI
- 84353161DM014A79 EUDAMED
- EMDN Code
- Q01020104 DENTAL IMPRESSION SILICONES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
VENTURA BITE 2.0 (2X50 ml) by Madespa, S.a. — 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 | 84353161DM014A79 | Class I | Active |
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Manufacturer
- Manufacturer
- Madespa, S.a.
- EUDAMED SRN
- ES-MF-000003915
Sources (1)
- EUDAMED 1f5044ff-7a06-4f02-ba1c-08e3ac6d4c6d 61 fields · synced Jul 9, 2026