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Radionuclide dose calibrator
EUDAMEDFDA UDIClass I (EU MDR)
Ref 0202020160Model RDC-VIK-202 with IBC-Lite
Identity
- Trade Name
- VIK202 FDA UDI
- Generic Name
- Radioisotope calibration system FDA UDI
- Device Name
- Radionuclide dose calibrator EUDAMEDMeasuring unit for the dose calibrator FDA UDI
- Model / Reference
- RDC-VIK-202 with IBC-Lite EUDAMED0202020160 EUDAMED0202020001 FDA UDI
- Description
- Measuring unit for the dose calibrator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08719324589000 EUDAMEDFDA UDI
- Basic UDI-DI
- 8719324589RDCJU EUDAMED
- Direct Marketing DI
- 08719324589000 EUDAMED
- 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
- Netherlands 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Radionuclide dose calibrator by Comecer Netherlands B.V. — 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 | 8719324589RDCJU | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Comecer Netherlands B.V.
- EUDAMED SRN
- NL-MF-000026292
Sources (2)
- EUDAMED f243f05f-a2f1-4c73-a88b-3d380e3006d4 61 fields · synced Sep 18, 2026
- FDA UDI 9ac6392d-52c2-4b99-b35c-c7719cd517e3 34 fields · synced May 29, 2026