Captus 4000e Thyroid Uptake System
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- Captus 4000e Thyroid Uptake System EUDAMEDFDA UDI
- Generic Name
- Thyroid-uptake nuclear medicine system FDA UDI
- Device Name
- The Captus 4000e is a PC based Thyroid Uptake System, on a ergonomically designed mobile stand. It includes a 1024 channel MCA, automated Quality Assurance, Thyroid Uptake Module, and Bioassay module. FDA UDI
- Model / Reference
- Captus 4000e Thyroid Uptake System EUDAMEDFDA UDI5430-30151 EUDAMED
- Description
- The Captus 4000e is a PC based Thyroid Uptake System, on a ergonomically designed mobile stand. It includes a 1024 channel MCA, automated Quality Assurance, Thyroid Uptake Module, and Bioassay module. FDA UDI
Identifiers
- Catalog Number
- 5430-30151 FDA UDI
- Primary DI / UDI-DI
- 00859942006096 EUDAMEDFDA UDI
- Basic UDI-DI
- 08599420061014S EUDAMED
- Direct Marketing DI
- 00859942006096 EUDAMED
- FDA Product Code
- IZD FDA UDI
- EMDN Code
- Z11029001 BETA/GAMMA DETECTORS EUDAMED
- GMDN Term
- Thyroid-uptake nuclear medicine system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 892.1320 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Hand-held-detector nuclear medicine system
Captus 4000e Thyroid Uptake System by Mirion Technologies (Capintec), Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08599420061014S | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Mirion Technologies (Capintec), Inc.
- EUDAMED SRN
- US-MF-000000770
- Authorised Representative
- Atlantico Systems, Ltd. IE-AR-000000208
Sources (2)
- EUDAMED 6faa969d-2f8e-4e79-a1d4-79eace7a6ced 61 fields · synced Jun 18, 2026
- FDA UDI 7b3ad8e1-06af-4fd0-b426-d1b3f2d42a43 35 fields · synced May 30, 2026