Captus 4000e Thyroid Uptake System with Well (2 in)

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 5430-30154Model Captus 4000e Thyroid Uptake System

by Mirion Technologies (Capintec), Inc.

Identity

Trade Name: Captus 4000e Thyroid Uptake System with Well (2 in) EUDAMED
Captus 4000e Thyroid Uptake System with 2 in 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, and Bioassay module. This model includes a well counter with 2 inch of lead shielding. FDA UDI
Model / Reference: Captus 4000e Thyroid Uptake System EUDAMED
5430-30154 EUDAMEDFDA 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, and Bioassay module. This model includes a well counter with 2 inch of lead shielding. FDA UDI

Identifiers

Catalog Number: 5430-30154 FDA UDI
Primary DI / UDI-DI: 00859942006423 EUDAMEDFDA UDI
Basic UDI-DI: 08599420061014S EUDAMED
Direct Marketing DI: 00859942006423 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 EUDAMED
Class I FDA UDI
Regulation Number: 892.1320 FDA UDI
Market of Registration: France EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Hand-held-detector nuclear medicine system

Captus 4000e Thyroid Uptake System with Well (2 in) 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

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 710fe97a-1729-4618-92a9-106e09bc26cd 61 fields · synced Jun 19, 2026
FDA UDI 3b7269e5-3e02-4e1c-8cca-f6330b490d6c 35 fields · synced May 29, 2026