Identity
- Trade Name
- GammaPro Standard EUDAMED
- Device Name
- GammaPro Standard EUDAMED
- Model / Reference
- K0019C01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- B619K0019C010P EUDAMED
- Basic UDI-DI
- ++B619K0019C01UW EUDAMED
- Direct Marketing DI
- B619K0019C010P EUDAMED
- EMDN Code
- Z11029001 BETA/GAMMA DETECTORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Hand-held-detector nuclear medicine system
GammaPro Standard by Kub Technologies Inc — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++B619K0019C01UW | Class IIa | Active |
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Manufacturer
- Manufacturer
- Kub Technologies Inc
- EUDAMED SRN
- US-MF-000026338
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 5ae1c93b-79fa-4a59-9663-ed6614cddf3c 61 fields · synced Jul 31, 2026