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Dimension EXL™ LOCI Vitamin D Calibrator
EUDAMEDClass B (EU MDR)
Ref 10711395Model IVDR_67_GLA_DUB-C_B_REAG_VITD CAL
Identity
- Trade Name
- Dimension EXL™ LOCI Vitamin D Calibrator EUDAMED
- Device Name
- IVDR_67_GLA_DUB-C_B_REAG_VITD CAL EUDAMED
- Model / Reference
- IVDR_67_GLA_DUB-C_B_REAG_VITD CAL EUDAMED10711395 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00842768037764 EUDAMED
- Basic UDI-DI
- 0405686901224V2 EUDAMED
- EMDN Code
- W0102152206 ANAEMIA RELATED/VITAMIN STANDARDS AND CALIBRATORS EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
No
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
Dimension EXL™ LOCI Vitamin D Calibrator 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 | 0405686901224V2 | Class B | Active |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
- EUDAMED SRN
- US-MF-000016336
- Authorised Representative
- Siemens Healthcare Diagnostics Manufacturing Limited IE-AR-000006763
Sources (1)
- EUDAMED 62dabf52-d758-43d9-a744-62dc26bab5bc 61 fields · synced Jun 19, 2026