Identity
- Trade Name
- Asserachrom® PAI-1 EUDAMED
- Device Name
- Asserachrom® PAI-1 EUDAMED
- Model / Reference
- 00949 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03607450009491 EUDAMED
- Basic UDI-DI
- B-03607450009491 EUDAMED
- EMDN Code
- W0103020506 PLASMINOGEN ACTIVATOR-INHIBITORS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Asserachrom® PAI-1 by Diagnostica Stago — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-03607450009491 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Diagnostica Stago
- EUDAMED SRN
- FR-MF-000017089
Sources (1)
- EUDAMED e886f46a-4410-4213-9f70-69a5f38f871c 61 fields · synced Jul 9, 2026