Identity
- Trade Name
- Anti-CCP (CLIA) EUDAMED
- Device Name
- Anti-CCP (CLIA) EUDAMED
- Model / Reference
- MCL03601E EUDAMEDMCL03602E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06926802604403 EUDAMED06926802604410 EUDAMED
- Basic UDI-DI
- B-06926802604403 EUDAMEDB-06926802604410 EUDAMED69268026MD72C00001V3 EUDAMED
- EMDN Code
- W01021112 ANTI-CYCLIC CITRULLINATED PEPTIDE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass B EUDAMED
- Market of Registration
- Netherlands 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Anti-CCP (CLIA) by Medcaptain Medical Technology Co., Ltd. — Class IVD General — IVDR, IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06926802604403 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06926802604403 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Medcaptain Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005925
- Authorised Representative
- R Sight B.V. NL-AR-000010445
Sources (4)
- EUDAMED bedc166e-85d0-4398-b63b-78ff005d2dd1 61 fields · synced Jul 29, 2026
- EUDAMED 0a15ee8c-ef8c-4171-8b6d-6bee10e16b4c 61 fields · synced May 17, 2026
- EUDAMED 02d9b3a3-ce79-4683-8ea3-59088a3a1f5c 61 fields · synced Jul 10, 2026
- EUDAMED c50c2ffa-0335-4c11-acec-f7bcabb111f0 61 fields · synced Jul 29, 2026