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Quantitative Analysis Kit for Three Tumor Markers (Flowcytometry Fluorescence M…
EUDAMEDClass IVD General (EU MDR)
Ref 1TM3B01
Identity
- Trade Name
- Quantitative Analysis Kit for Three Tumor Markers (Flowcytometry Fluorescence Method) EUDAMED
- Device Name
- Quantitative Analysis Kit for Three Tumor Markers (Flowcytometry Fluorescence Method) EUDAMED
- Model / Reference
- 1TM3B01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810173656870 EUDAMED
- Basic UDI-DI
- B-00810173656870 EUDAMED
- EMDN Code
- W01021499 MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Ireland 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
Quantitative Analysis Kit for Three Tumor Markers (Flowcytometry Fluorescence M… by Healgen Scientific Limited Liability Company — Class IVD General — IVDD…
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-00810173656870 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Healgen Scientific Limited Liability Company
- EUDAMED SRN
- US-MF-000018839
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED a08038f2-fb99-4fe2-84b0-09d42af5d909 61 fields · synced Oct 6, 2026