Identity
- Trade Name
- Trigger Solution EUDAMED
- Device Name
- Trigger Solution EUDAMED
- Model / Reference
- 640mL EUDAMEDCA1002P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936595763126 EUDAMED
- Basic UDI-DI
- 6970291981002A2 EUDAMED
- EMDN Code
- W01029003 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Trigger Solution by Medicalsystem Biotechnology Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 6970291981002A2 | Class A | Active |
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Manufacturer
- Manufacturer
- MedicalSystem Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010246
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED ae539251-6de9-4a3a-b4e8-8cc4ef26cb43 61 fields · synced Jul 23, 2026