← Back to catalogue
Atellica CH Calcium_2 (CA_2)
EUDAMEDClass B (EU MDR)
Ref 11645760Model IVDR_67_TTN_DUB-C_B_REAG_CA_2
Identity
- Trade Name
- Atellica CH Calcium_2 (CA_2) EUDAMED
- Device Name
- IVDR_67_TTN_DUB-C_B_REAG_CA_2 EUDAMED
- Model / Reference
- IVDR_67_TTN_DUB-C_B_REAG_CA_2 EUDAMED11645760 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00630414654058 EUDAMED
- Basic UDI-DI
- 0405686900772VX EUDAMED
- Unit of Use DI
- 00630414322124 EUDAMED
- EMDN Code
- W01010303 CALCIUM EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Atellica CH Calcium_2 (CA_2) by Siemens Healthcare Diagnostics — 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 | 0405686900772VX | Class B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
- EUDAMED SRN
- US-MF-000016560
- Authorised Representative
- Siemens Healthcare Diagnostics Manufacturing Limited IE-AR-000006763
Sources (1)
- EUDAMED 2006bb11-d700-439d-9695-9264cfae4c51 61 fields · synced Jul 24, 2026