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Atellica CH Iron3 (Iron3)
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 11537211Model IVDR_67_TTN_DUB-C_B_REAG_Iron3
Identity
- Trade Name
- Atellica CH Iron3 (Iron3) EUDAMEDFDA UDI
- Generic Name
- Iron IVD, kit, spectrophotometry FDA UDI
- Device Name
- IVDR_67_TTN_DUB-C_B_REAG_Iron3 EUDAMEDIron (Iron3) Atellica CH FDA UDI
- Model / Reference
- 11537211 EUDAMEDFDA UDIIVDR_67_TTN_DUB-C_B_REAG_Iron3 EUDAMED
- Description
- Iron (Iron3) Atellica CH FDA UDI
Identifiers
- Catalog Number
- 11537211 FDA UDI
- Primary DI / UDI-DI
- 00630414610849 EUDAMEDFDA UDI
- Basic UDI-DI
- 0405686902345VN EUDAMED
- Unit of Use DI
- 00630414305011 EUDAMED
- FDA Product Code
- JIY FDA UDI
- EMDN Code
- W0102070106 IRON (IC) EUDAMED
- GMDN Term
- Iron IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1410 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Iron IVD, kit, spectrophotometry
Atellica CH Iron3 (Iron3) by Siemens Healthcare Diagnostics — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (2)
- FDA UDI d01e2639-ec03-4d45-b8a1-6434a44ddf0d 36 fields · synced Jul 31, 2026
- EUDAMED 4dd3b2da-2103-456d-9bec-87d15ca1218b 61 fields · synced Jul 31, 2026