Identity
- Model / Reference
- PSD EUDAMEDDS80331 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08445594007066 EUDAMED
- Basic UDI-DI
- 8445594_PILAR_SOBRE_HC EUDAMED
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
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
The DS80331 medical device is a Class IIb EM EXACT, S.A. device used for the measurement of human product sterilization rates. It is designed for use in hospitals and other healthcare settings where precise temperature control is required. The device features a self-testing mechanism to ensure accurate results.
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_PILAR_SOBRE_HC | Class IIb | Active |
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Manufacturer
- Manufacturer
- Em Exact, S.a.
- EUDAMED SRN
- ES-MF-000010830
Sources (1)
- EUDAMED 39bd8333-96d8-4067-a86f-aa2825cd46a5 61 fields · synced Jul 14, 2026