Identity
- Trade Name
- CRC-55tPET EUDAMEDCapintec Dose Calibrator FDA UDI
- Generic Name
- Radioisotope calibration system FDA UDI
- Device Name
- Radioisotope Dose Calibrator FDA UDI
- Model / Reference
- CRC-55tR EUDAMED5130-3235 EUDAMEDCRC-55tPET FDA UDI
- Description
- Radioisotope Dose Calibrator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00859942006010 EUDAMEDFDA UDI
- Basic UDI-DI
- 08599420061004Q EUDAMED
- Direct Marketing DI
- 00859942006010 EUDAMED
- 510(k) Number
- K101452 FDA UDI
- FDA Product Code
- KPT FDA UDI
- EMDN Code
- Z11029005 AUTOMATIC DOSE CALIBRATORS EUDAMED
- GMDN Term
- Radioisotope calibration system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1360 FDA UDI
- Market of Registration
- Spain 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
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
CRC-55tPET 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 | 08599420061004Q | 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 92c564a1-621f-49fd-b385-57c42ad3b0ec 61 fields · synced Jun 19, 2026
- FDA UDI df1d450a-4117-401d-a151-9986c24ccb08 34 fields · synced May 30, 2026