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TeraRecon Cardiovascular.Calcification.CT
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 1
Identity
- Trade Name
- TeraRecon Cardiovascular.Calcification.CT EUDAMED
- Device Name
- TeraRecon Cardiovascular.Calcification.CT EUDAMED
- Model / Reference
- 1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B220CARDIOVASCCALCT10 EUDAMED
- Basic UDI-DI
- ++B220CALCIFICATIONCTLV EUDAMED
- Direct Marketing DI
- +B220CARDIOVASCCALCT10 EUDAMED
- EMDN Code
- Z11030592 RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
TeraRecon Cardiovascular.Calcification.CT by Terarecon Inc. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250288 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | ++B220CALCIFICATIONCTLV | Class IIa | Active |
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Manufacturer
- Manufacturer
- TeraRecon, Inc.
- EUDAMED SRN
- US-MF-000008772
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 04a45898-e9f9-413b-8bb6-b3bf85202729 61 fields · synced Jul 10, 2026
- FDA 510(k) K250288 1 fields · synced May 18, 2026