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Captus 4000e Thyroid Uptake System with Well (1 in)
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 5430-30152Model Captus 4000e Thyroid Uptake System
Identity
- Trade Name
- Captus 4000e Thyroid Uptake System with Well (1 in) EUDAMEDCaptus 4000e Thyroid Uptake System with Well FDA 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, Bioassay module, Wipe Test Module, and Lab Tests. FDA UDI
- Model / Reference
- Captus 4000e Thyroid Uptake System EUDAMED5430-30152 EUDAMEDCaptus 4000e Thyroid System with Well FDA UDI
- 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, Bioassay module, Wipe Test Module, and Lab Tests. FDA UDI
Identifiers
- Catalog Number
- 5430-30152 FDA UDI
- Primary DI / UDI-DI
- 00859942006102 EUDAMEDFDA UDI
- Basic UDI-DI
- 08599420061014S EUDAMED
- Direct Marketing DI
- 00859942006102 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Yes
EUDAMED
Incorporates Medicinal Product
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Captus 4000e Thyroid Uptake System with Well (1 in) by Mirion Technologies (Capintec), Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
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 101253db-3058-4eea-b864-1c6257d7f256 61 fields · synced Jul 17, 2026
- FDA UDI 528e5b6a-38fe-4abe-98db-c17e167d0a12 35 fields · synced May 29, 2026