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CEDIA Cardiac TDM Multi-Calibrators
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 100001
Identity
- Trade Name
- CEDIA Cardiac TDM Multi-Calibrators FDA UDI
- Generic Name
- Multiple-therapy therapeutic drug monitoring IVD, calibrator FDA UDI
- Device Name
- CEDIA Cardiac TDM Multi-Calibrators EUDAMED
- Model / Reference
- 100001 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884883001213 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884883001213 EUDAMED
- 510(k) Number
- K962269 FDA UDI
- FDA Product Code
- JIX FDA UDI
- EMDN Code
- W01021521 MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS EUDAMED
- GMDN Term
- Multiple-therapy therapeutic drug monitoring IVD, calibrator FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1150 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
CEDIA Cardiac TDM Multi-Calibrators by Microgenics Corporation — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-00884883001213 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Microgenics Corporation
- EUDAMED SRN
- US-MF-000030375
- Authorised Representative
- B·R·A·H·M·S GmbH DE-AR-000026031
Sources (2)
- EUDAMED d777b38f-4909-41d9-99a7-611ffe91edcb 61 fields · synced Jul 27, 2026
- FDA UDI 69309b53-a5e1-44ec-9204-5aa5b26c2e25 33 fields · synced May 30, 2026