Identity
- Trade Name
- Pre-trigger Solution EUDAMED
- Device Name
- Pre-trigger Solution EUDAMED
- Model / Reference
- KR-PTS-01500C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973600790036 EUDAMED
- Basic UDI-DI
- 697360079002JK EUDAMED
- EMDN Code
- W0599 IVD GENERAL USE CONSUMABLE DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- France 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Pre-trigger Solution by Xiamen Innodx Biotech Co., Ltd. — Class A — CE/MDR — 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 | 697360079002JK | Class A | Active |
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Manufacturer
- Manufacturer
- Xiamen Innodx Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000041071
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED c5ddaf85-d9a8-4ce0-8121-04c0a756362a 61 fields · synced Oct 6, 2026