← Back to catalogue
Mycoplasma Pneumoniae IgG Antibody Chemiluminescent Immunoassay Kit
EUDAMEDClass B (EU MDR)
Ref IM4410040Model IM4410040 IM4411040 IM4414040 IM4415040
Identity
- Device Name
- Mycoplasma Pneumoniae IgG Antibody Chemiluminescent Immunoassay Kit EUDAMED
- Model / Reference
- IM4410040 IM4411040 IM4414040 IM4415040 EUDAMEDIM4410040 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950617416784 EUDAMED
- Basic UDI-DI
- 69506174IM441040D7 EUDAMED
- Direct Marketing DI
- 06950617416784 EUDAMED
- EMDN Code
- W0105010802 MYCOPLASMA ANTIBODY ASSAYS EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Spain 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
New Device
No
EUDAMED
Mycoplasma Pneumoniae IgG Antibody Chemiluminescent Immunoassay Kit by Maccura Biotechnology Co., Ltd. — Class B — IVDR — listed in EUDAMED
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 | 69506174IM441040D7 | Class B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Maccura Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000014618
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED cf50e713-85a9-499a-bb0b-ca8c000af183 61 fields · synced Jun 19, 2026