Identity
- Trade Name
- Thyroid Neck Phantom EUDAMEDCapintec Neck Phantom FDA UDI
- Generic Name
- Nuclear medicine phantom, anthropomorphic FDA UDI
- Device Name
- Neck Phantom EUDAMEDThyroid Uptake Neck Phantom FDA UDI
- Model / Reference
- 5230-0038 EUDAMEDFDA UDI
- Description
- Thyroid Uptake Neck Phantom FDA UDI
Identifiers
- Catalog Number
- 5230-0038 FDA UDI
- Primary DI / UDI-DI
- 00859942006324 EUDAMEDFDA UDI
- Basic UDI-DI
- 085994200610654 EUDAMED
- Direct Marketing DI
- 00859942006324 EUDAMED
- FDA Product Code
- IYP FDA UDI
- EMDN Code
- Z11029080 VARIOUS INSTRUMENTS FOR NUCLEAR MEDICINE - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Nuclear medicine phantom, anthropomorphic FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.1370 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Thyroid Neck Phantom by Mirion Technologies (Capintec), Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 085994200610654 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 e0cc17ec-3818-46cf-a44e-8de58978a1e4 61 fields · synced Jul 22, 2026
- FDA UDI c72a8c92-beee-4392-a5e7-7a1c237c2960 35 fields · synced May 30, 2026