Identity
- Model / Reference
- PSD EUDAMEDDS46432 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08445594008599 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 DS46432 medical device is a Class IIb instrument used in endocrine disruptor testing, which measures the effect of various substances on human endocrine function. It is manufactured by EM EXACT, S.A. and has been certified as meeting certain standards for sterility and conformity to regulatory requirements.
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 967d8d31-d0fc-4a09-9fd3-7d9d95c940d7 61 fields · synced Jul 25, 2026