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RF-IgG Chemiluminescent Immunoassay Kit
EUDAMEDClass B (EU MDR)
Ref IM4406269 Model IM4402269 IM4403269 IM4406269 IM4407269 IM4410269 IM4411269 IM4414269 IM4415269Ref IM4410269Ref IM4415269 Ref IM4403269Ref IM4407269Ref IM4410269 Ref IM4411269Ref IM4414269 Ref IM4411269 Ref IM4406269Ref IM4414269Ref IM4415269
Identity
- Device Name
- RF-IgG Chemiluminescent Immunoassay Kit EUDAMED
- Model / Reference
- IM4402269 IM4403269 IM4406269 IM4407269 IM4410269 IM4411269 IM4414269 IM4415269 EUDAMEDIM4406269 EUDAMEDIM4410269 EUDAMEDIM4415269 EUDAMEDIM4403269 EUDAMEDIM4407269 EUDAMEDIM4411269 EUDAMEDIM4414269 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950617439400 EUDAMEDD-IM4410269J9 EUDAMED06950617439370 EUDAMEDD-IM4403269JK EUDAMEDD-IM4407269KF EUDAMED06950617439356 EUDAMEDD-IM4411269JG EUDAMED06950617439363 EUDAMED06950617439349 EUDAMEDD-IM4406269K8 EUDAMEDD-IM4414269K5 EUDAMEDD-IM4415269KC EUDAMED
- Basic UDI-DI
- 69506174IM441269E9 EUDAMEDB-IM4410269J9 EUDAMEDB-IM4403269JK EUDAMEDB-IM4407269KF EUDAMEDB-IM4411269JG EUDAMEDB-IM4406269K8 EUDAMEDB-IM4414269K5 EUDAMEDB-IM4415269KC EUDAMED
- Direct Marketing DI
- 06950617439400 EUDAMED06950617439370 EUDAMED06950617439356 EUDAMED06950617439363 EUDAMED06950617439349 EUDAMED
- EMDN Code
- W01021199 RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER EUDAMEDW01021110 RHEUMATOID FACTORS EUDAMED
Classification
- Device Class
- Class B EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMEDEUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
EUDAMEDEUDAMED
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
RF-IgG Chemiluminescent Immunoassay Kit by Maccura Biotechnology Co., Ltd. — Class B — 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 | 69506174IM441269E9 | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 69506174IM441269E9 | Class B | Active |
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Manufacturer
- Manufacturer
- Maccura Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000014618
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (12)
- EUDAMED 71ee6db9-c161-4e95-915c-95e9c0c4a6ab 61 fields · synced Oct 7, 2026
- EUDAMED c68a65f7-cca5-4ede-9f8e-019dee868373 61 fields · synced May 16, 2026
- EUDAMED 740f47e9-65e1-4d4f-a017-d4e4c56b4381 61 fields · synced May 16, 2026
- EUDAMED e2fee598-c0fe-44ca-8286-03450dd352cb 61 fields · synced May 17, 2026
- EUDAMED abe5d542-b557-4827-a241-b7d21872f432 61 fields · synced May 17, 2026
- EUDAMED f3630164-ac87-458f-ba58-f6b88f50e920 61 fields · synced May 17, 2026
- EUDAMED e2b11227-fa70-4900-9495-8df140f9dacc 61 fields · synced May 18, 2026
- EUDAMED f42696e5-54b8-4f59-8b5f-c2398f516554 61 fields · synced May 18, 2026
- EUDAMED c8f1d099-584c-4ad5-a4dd-5a225e26c807 61 fields · synced May 19, 2026
- EUDAMED e31dc4ce-9b0d-487e-986c-13856dee4e15 61 fields · synced May 19, 2026
- EUDAMED a03e7b6a-3976-4934-a307-7046b1b9e0dc 61 fields · synced May 19, 2026
- EUDAMED ab511d89-6e59-442c-94d8-9663bfe6b404 61 fields · synced May 19, 2026