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ReLIA
EUDAMEDClass A (EU MDR)
Ref RG910015Model RG710, RG726-2, RG726-3, RG726-4, RG726-5, RG726-6Ref RG910007Ref RF910009Model RF810, RF820Ref RG910006Ref RG910014Ref RF910008Ref RF16207-50TRef RF16057-20TRef RF16049-20TRef RG16276-50TRef RG16138-20TRef RF16214-50TRef RF16097-20TRef RG16105-20TRef RF16043-20TRef RF16216-50TRef RF16355-50TRef RG16364-20TRef RF16205-20TRef RF16227-50TRef RF16059-20TRef RF16230-50TRef RF16047-20TRef RF16213-50TRef RG16139-20TRef RF16045-20TRef RG16085-20TRef RF16395-50TRef RF16041-20TRef RF16377-50TRef RF16069-20TRef RF16219-50TRef RG16359-20TRef RF16133-20TRef RF16053-20TRef RG16270-50TRef RG16111-20TRef RF16021-20TRef RF16065-20TRef RG16121-20TRef RG16379-50TRef RF16203-20TRef RG16367-50TRef RF16220-50TRef RG16376-50TRef RF16229-50TRef RF16393-50TRef RF16067-20TRef RG16382-20TRef RF16039-20TRef RF16197-20TRef RF16145-20TRef RF16400-50TRef RF16193-20TRef RF16228-50TRef RF16226-50TRef RG16370-50TRef RG16109-20TRef RG16288-50TRef RF16163-20TRef RF16358-20TRef RF16135-20TRef RG16368-50TRef RF16392-50TRef RG16119-20TRef RF16209-50TRef RF16095-20TRef RF16215-50TRef RF16389-20TRef RF16375-50TRef RG16273-50T
Identity
- Trade Name
- ReLIA EUDAMED
- Device Name
- Immunoassay Diagnostic Instrument EUDAMEDFluorescence lmmunoassay Analyzer EUDAMEDMyoglobin Test (Fluorescence Immunoassay) EUDAMEDSoluble Growth Stimulation Expressed Gene 2 Test (Fluorescence Immunoassay) EUDAMEDHeart Type Fatty Acid Binding Protein Test (Fluorescence Immunoassay) EUDAMEDCardiac Troponin I /Creatine Kinase Isoenzyme-MB/Myoglobin Test (Colloidal Gold) EUDAMEDSerum Amyloid A Protein/C-Reactive Protein Test (Colloidal Gold) EUDAMEDCapillary Blood Procalcitonin Test (Fluorescence Immunoassay) EUDAMEDInterleukin-6 Test (Fluorescence Immunoassay) EUDAMEDMyoglobin Test (Colloidal Gold) EUDAMEDN-terminal pro-Brain Natriuretic Peptide Test (Fluorescence Immunoassay) EUDAMEDs100β Test (Fluorescence Immunoassay) EUDAMEDSerum Amyloid A Protein Test (Fluorescence Immunoassay) EUDAMEDAnti-Mullerian Hormone Test (Colloidal Gold) EUDAMEDCardiac troponin I/N-terminal pro-Brain Natriuretic Peptide/D-Dimer Test (Fluorescence Immunoassay) EUDAMEDLipoprotein-associated phospholipase A2 test (Fluorescence Immunoassay) EUDAMEDCystatin C Test (Fluorescence Immunoassay) EUDAMEDCardiac Troponin I / Heart-type Fatty Acid-binding Protein Test (Fluorescence Immunoassay) EUDAMEDD-Dimer Test (Fluorescence Immunoassay) EUDAMEDFibrinogen/Fibrin Degradation Products Test (Colloidal Gold) EUDAMEDHigh Sensitivity Cardiac Troponin I (hs-cTnI) Test (Fluorescence Immunoassay) EUDAMEDCystatin C Test (Colloidal Gold) EUDAMEDBeta2 - Microglobulin Test (Fluorescence Immunoassay) EUDAMEDProcalcitonin / Interleukin 6 Test (Fluorescence Immunoassay) EUDAMEDNeutrophil Gelatinase-associated Lipocalin/Microalbumin Test (Fluorescence Immunoassay) EUDAMEDAnti-Mullerian Hormone Test (Fluorescence Immunoassay) EUDAMEDHeart Type Fatty Acid Binding Protein Test (Colloidal Gold) EUDAMEDFull-Scale C-Reactive Protein Test (CRP) (Colloidal Gold) EUDAMEDNeutrophil Gelatinase-associated Lipocalin Test (Fluorescence Immunoassay) EUDAMEDCardiac Troponin I /Creatine Kinase Isoenzyme-MB /Myoglobin Test (Fluorescence Immunoassay) EUDAMEDN-terminal pro-Brain Natriuretic Peptide Test (Colloidal Gold) EUDAMEDNeutrophil Gelatinase-Associated Lipocalin Test (Colloidal Gold) EUDAMEDGastrin 17 Test (Fluorescence Immunoassay) EUDAMEDD-Dimer Test (Colloidal Gold) EUDAMEDMicroalbumin Test (Fluorescence Immunoassay) EUDAMEDNeutrophil Gelatinase-Associated Lipocalin/Microalbumin Test (Colloidal Gold) EUDAMEDFull-Scale C-Reactive Protein Test (CRP) (Fluorescence Immunoassay) EUDAMEDCardiac Troponin T Test (Fluorescence Immunoassay) EUDAMEDProgesterone Test (Fluorescence Immunoassay) EUDAMEDHomocysteine Test (Fluorescence Immunoassay) EUDAMEDMyeloperoxidase Test (Fluorescence Immunoassay) EUDAMEDProcalcitonin Test (Colloidal Gold) EUDAMEDB-type Natriuretic Peptide Test (Fluorescence Immunoassay) EUDAMEDGlycosylated Hemoglobin (HbA1c) Assay Kit (Fluorescence Immunoassay) EUDAMEDThe β-subunit of Human Chorionic Gonadotropin Test (Fluorescence Immunoassay) EUDAMEDMyeloperoxidase Test (Colloidal Gold) EUDAMEDGrowth Differentiation Factor-15 Test (Fluorescence Immunoassay) EUDAMEDSerum Amyloid A Protein Test (Colloidal Gold) EUDAMED
- Model / Reference
- RG710, RG726-2, RG726-3, RG726-4, RG726-5, RG726-6 EUDAMEDRG910015 EUDAMEDRG910007 EUDAMEDRF810, RF820 EUDAMEDRF910009 EUDAMEDRG910006 EUDAMEDRG910014 EUDAMEDRF910008 EUDAMEDRF16207-50T EUDAMEDRF16057-20T EUDAMEDRF16049-20T EUDAMEDRG16276-50T EUDAMEDRG16138-20T EUDAMEDRF16214-50T EUDAMEDRF16097-20T EUDAMEDRG16105-20T EUDAMEDRF16043-20T EUDAMEDRF16216-50T EUDAMEDRF16355-50T EUDAMEDRG16364-20T EUDAMEDRF16205-20T EUDAMEDRF16227-50T EUDAMEDRF16059-20T EUDAMEDRF16230-50T EUDAMEDRF16047-20T EUDAMEDRF16213-50T EUDAMEDRG16139-20T EUDAMEDRF16045-20T EUDAMEDRG16085-20T EUDAMEDRF16395-50T EUDAMEDRF16041-20T EUDAMEDRF16377-50T EUDAMEDRF16069-20T EUDAMEDRF16219-50T EUDAMEDRG16359-20T EUDAMEDRF16133-20T EUDAMEDRF16053-20T EUDAMEDRG16270-50T EUDAMEDRG16111-20T EUDAMEDRF16021-20T EUDAMEDRF16065-20T EUDAMEDRG16121-20T EUDAMEDRG16379-50T EUDAMEDRF16203-20T EUDAMEDRG16367-50T EUDAMEDRF16220-50T EUDAMEDRG16376-50T EUDAMEDRF16229-50T EUDAMEDRF16393-50T EUDAMEDRF16067-20T EUDAMEDRG16382-20T EUDAMEDRF16039-20T EUDAMEDRF16197-20T EUDAMEDRF16145-20T EUDAMEDRF16400-50T EUDAMEDRF16193-20T EUDAMEDRF16228-50T EUDAMEDRF16226-50T EUDAMEDRG16370-50T EUDAMEDRG16109-20T EUDAMEDRG16288-50T EUDAMEDRF16163-20T EUDAMEDRF16358-20T EUDAMEDRF16135-20T EUDAMEDRG16368-50T EUDAMEDRF16392-50T EUDAMEDRG16119-20T EUDAMEDRF16209-50T EUDAMEDRF16095-20T EUDAMEDRF16215-50T EUDAMEDRF16389-20T EUDAMEDRF16375-50T EUDAMEDRG16273-50T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971354101511 EUDAMED06971354101467 EUDAMED06971354101412 EUDAMED06971354101474 EUDAMED06971354101504 EUDAMED06971354101443 EUDAMED06971354100118 EUDAMED06971354100170 EUDAMED06971354100071 EUDAMED06971354101207 EUDAMED06971354101290 EUDAMED06971354100200 EUDAMED06971354100316 EUDAMED06971354101634 EUDAMED06971354100132 EUDAMED06971354100262 EUDAMED06971354101979 EUDAMED06971354101580 EUDAMED06971354100606 EUDAMED06971354100439 EUDAMED06971354100224 EUDAMED06971354100507 EUDAMED06971354100057 EUDAMED06971354100187 EUDAMED06971354101337 EUDAMED06971354100088 EUDAMED06971354101092 EUDAMED06971354101962 EUDAMED06971354100194 EUDAMED06971354101863 EUDAMED06971354100453 EUDAMED06971354100309 EUDAMED06971354101535 EUDAMED06971354100279 EUDAMED06971354100101 EUDAMED06971354101122 EUDAMED06971354100651 EUDAMED06971354100125 EUDAMED06971354100477 EUDAMED06971354101658 EUDAMED06971354101757 EUDAMED06971354101948 EUDAMED06971354101665 EUDAMED06971354100323 EUDAMED06971354101733 EUDAMED06971354100484 EUDAMED06971354101573 EUDAMED06971354100330 EUDAMED06971354101788 EUDAMED06971354100033 EUDAMED06971354100521 EUDAMED06971354100361 EUDAMED06971354102006 EUDAMED06971354100538 EUDAMED06971354100460 EUDAMED06971354100415 EUDAMED06971354101696 EUDAMED06971354101702 EUDAMED06971354101368 EUDAMED06971354100576 EUDAMED06971354101481 EUDAMED06971354100446 EUDAMED06971354101672 EUDAMED06971354101542 EUDAMED06971354101177 EUDAMED06971354100040 EUDAMED06971354100408 EUDAMED06971354100231 EUDAMED06971354101924 EUDAMED06971354101856 EUDAMED06971354101160 EUDAMED
- Basic UDI-DI
- 697135410RG710BV EUDAMED697135410RF810BT EUDAMEDB-06971354100118 EUDAMEDB-06971354100170 EUDAMEDB-06971354100071 EUDAMEDB-06971354101207 EUDAMEDB-06971354101290 EUDAMEDB-06971354100200 EUDAMEDB-06971354100316 EUDAMEDB-06971354101634 EUDAMEDB-06971354100132 EUDAMEDB-06971354100262 EUDAMEDB-06971354101979 EUDAMEDB-06971354101580 EUDAMEDB-06971354100606 EUDAMEDB-06971354100439 EUDAMEDB-06971354100224 EUDAMEDB-06971354100507 EUDAMEDB-06971354100057 EUDAMEDB-06971354100187 EUDAMEDB-06971354101337 EUDAMEDB-06971354100088 EUDAMEDB-06971354101092 EUDAMEDB-06971354101962 EUDAMEDB-06971354100194 EUDAMEDB-06971354101863 EUDAMEDB-06971354100453 EUDAMEDB-06971354100309 EUDAMEDB-06971354101535 EUDAMEDB-06971354100279 EUDAMEDB-06971354100101 EUDAMEDB-06971354101122 EUDAMEDB-06971354100651 EUDAMEDB-06971354100125 EUDAMEDB-06971354100477 EUDAMEDB-06971354101658 EUDAMEDB-06971354101757 EUDAMEDB-06971354101948 EUDAMEDB-06971354101665 EUDAMEDB-06971354100323 EUDAMEDB-06971354101733 EUDAMEDB-06971354100484 EUDAMEDB-06971354101573 EUDAMEDB-06971354100330 EUDAMEDB-06971354101788 EUDAMEDB-06971354100033 EUDAMEDB-06971354100521 EUDAMEDB-06971354100361 EUDAMEDB-06971354102006 EUDAMEDB-06971354100538 EUDAMEDB-06971354100460 EUDAMEDB-06971354100415 EUDAMEDB-06971354101696 EUDAMEDB-06971354101702 EUDAMEDB-06971354101368 EUDAMEDB-06971354100576 EUDAMEDB-06971354101481 EUDAMEDB-06971354100446 EUDAMEDB-06971354101672 EUDAMEDB-06971354101542 EUDAMEDB-06971354101177 EUDAMEDB-06971354100040 EUDAMEDB-06971354100408 EUDAMEDB-06971354100231 EUDAMEDB-06971354101924 EUDAMEDB-06971354101856 EUDAMEDB-06971354101160 EUDAMED
- EMDN Code
- W02010399 INTEGRATED / MODULAR CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER EUDAMEDW01021304 MYOGLOBIN EUDAMEDW01021314 ST2 EUDAMEDW0102019099 SPECIFIC PROTEINS - OTHER EUDAMEDW01021499 MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER EUDAMEDW01021199 RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER EUDAMEDW0102069013 PROCALCITONIN EUDAMEDW01030609 INTERLEUKIN 6 (IL-6) EUDAMEDW01021301 BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES) EUDAMEDW0102050215 ANTI-MULLERIAN HORMONE EUDAMEDW01021312 LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2 EUDAMEDW0102019008 CYSTATIN C EUDAMEDW0103020503 D-DIMER EUDAMEDW0103020502 FIBRINOGEN DEGRADATION PRODUCTS EUDAMEDW01021306 TROPONIN I/T EUDAMEDW0102039002 BETA2-MICROGLOBULIN EUDAMEDW01021109 C-REACTIVE PROTEIN EUDAMEDW0102060207 NEUTROPHIL GELATINASE ASSOCIATED LIPOCALIN (LIPOCALIN 2) EUDAMEDW0102069001 GASTRIN EUDAMEDW0102160101 ALBUMIN INCL. UALBUMIN RT & POC EUDAMEDW0102050106 PROGESTERONE EUDAMEDW01021307 HOMOCYSTEINE EUDAMEDW01021310 MYELOPEROXIDASE EUDAMEDW0101060107 HBA1C TEST STRIPS EUDAMEDW0102050206 B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT) EUDAMEDW0102060499 ENDOCRINE HORMONES (GROWTH FACTORS) - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Slovenia EUDAMED
Clinical & Handling
Sterile
No
EUDAMEDEUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMEDEUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMEDEUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMEDEUDAMED
New Device
No
EUDAMED
ReLIA by ReLIA Biotechnologies (Jiangsu), Inc. — Class A — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 697135410RG710BV | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 697135410RG710BV | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ReLIA Biotechnologies (Jiangsu), Inc.
- EUDAMED SRN
- CN-MF-000042042
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (71)
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