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Anti-Scl-70 Antibody Chemiluminescent Immunoassay Kit
EUDAMEDClass B (EU MDR)
Ref IM4422259Model IM4410259 IM4411259 IM4415259 IM4422259
Identity
- Device Name
- Anti-Scl-70 Antibody Chemiluminescent Immunoassay Kit EUDAMED
- Model / Reference
- IM4410259 IM4411259 IM4415259 IM4422259 EUDAMEDIM4422259 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950617407034 EUDAMED
- Basic UDI-DI
- 69506174IM441259E6 EUDAMED
- Direct Marketing DI
- 06950617407034 EUDAMED
- EMDN Code
- W0102100110 SCL-70 EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
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
Anti-Scl-70 Antibody Chemiluminescent Immunoassay Kit by Maccura Biotechnology Co., Ltd. — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 69506174IM441259E6 | 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 (1)
- EUDAMED 2eb42ca4-0415-4ebd-8bfc-f75ecfa8dca8 61 fields · synced Jun 18, 2026