Identity
- Trade Name
- Reaction Cup EUDAMED
- Device Name
- Reaction Cup EUDAMED
- Model / Reference
- RC-00 EUDAMEDPRC-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973600799886 EUDAMED06973600799923 EUDAMED
- Basic UDI-DI
- 69736007900909S EUDAMED
- EMDN Code
- W0503010280 SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER ACCESSORIES 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
No
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
Reaction Cup by Xiamen Innodx Biotech 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 | 69736007900909S | 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 (2)
- EUDAMED bb109fd4-bb5f-46f6-aab7-fa84a6140be8 61 fields · synced Oct 6, 2026
- EUDAMED 06408957-8e59-4513-9297-3aa0a322b471 61 fields · synced May 17, 2026