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Rheumatoid factor (RF), 5 mL Latex, 1 mL Positive control, 1 mL Negative Control
EUDAMEDClass IVD General (EU MDR)
Ref 101-0218
Identity
- Trade Name
- Rheumatoid factor (RF), 5 mL Latex, 1 mL Positive control, 1 mL Negative Control EUDAMED
- Device Name
- Rheumatoid factor (RF), 5 mL Latex, 1 mL Positive control, 1 mL Negative Control EUDAMED
- Model / Reference
- 101-0218 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-084360385655653HB EUDAMED
- Basic UDI-DI
- B-084360385655653HB EUDAMED
- EMDN Code
- W01021110 RHEUMATOID FACTORS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
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
Rheumatoid factor (RF), 5 mL Latex, 1 mL Positive control, 1 mL Negative Control by Chronolab Systems, S.L. — Class IVD General — IVDD — listed in EUDAMED
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-084360385655653HB | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Chronolab Systems, S.L.
- EUDAMED SRN
- ES-MF-000017043
Sources (1)
- EUDAMED 2f4043df-2dd5-4fb8-adbf-4dcf95d7ddeb 61 fields · synced Jun 18, 2026