Identity
- Model / Reference
- PUI EUDAMEDFAT-20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08445594002061 EUDAMED
- Basic UDI-DI
- 8445594_PUNTA_INSER_YU EUDAMED
- EMDN Code
- Q010280 PROSTHETIC DENTISTRY DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Fat-20 by Em Exact, 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 | 8445594_PUNTA_INSER_YU | Class I | Active |
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Manufacturer
- Manufacturer
- Em Exact, S.a.
- EUDAMED SRN
- ES-MF-000010830
Sources (1)
- EUDAMED eb99bb0d-43fc-4c86-9ad7-4867a529a469 61 fields · synced Aug 4, 2026