Identity
- Trade Name
- Ypeen EUDAMED
- Device Name
- YPEEN EUDAMED
- Model / Reference
- 4221130PE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08594747001090 EUDAMED
- Basic UDI-DI
- 859474710000282P EUDAMED
- EMDN Code
- Q01020101 DENTAL IMPRESSION ALGINATES 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
Ypeen by SpofaDental 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 | 859474710000282P | Class I | Active |
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Manufacturer
- Manufacturer
- SpofaDental a.s.
- EUDAMED SRN
- CZ-MF-000000945
Sources (1)
- EUDAMED 59be6446-a11b-4972-ae2d-0a37d0bcc03d 61 fields · synced Jul 20, 2026